International Regulatory Strategy Director Manager

Role Purpose & Context

Role Summary

As our International Regulatory Strategy Director Manager, you'll be the brains behind our global compliance efforts, making sure our products can get to market and stay there. Day-to-day, this means you'll be setting the regulatory direction for an entire business unit, leading a fair-sized team of regulatory professionals across different regions. You're not just reacting to regulations; you're anticipating them and building strategies to navigate the tricky bits. This role sits right at the intersection of product development, commercial strategy, and legal compliance. You'll be translating complex regulatory landscapes into clear, actionable plans that our R&D, Sales, and Marketing teams use to make critical decisions. Think of yourself as the ultimate gatekeeper and enabler for market access. When you do this job well, we launch new products faster, expand into new countries smoothly, and avoid costly regulatory delays or, worse, fines and product recalls. If it's not done well, we could be looking at significant financial penalties, reputational damage, and products stuck on shelves. The challenge? The regulatory world is a constantly moving target, and you've got to lead a team through that ambiguity while also managing internal expectations. The reward? Seeing your strategic thinking directly enable multi-million pound product launches and knowing you're protecting the company's future.

Reporting Structure

• Reports to: Director, International Regulatory Strategy
• Direct reports: Roughly 10-25 people, including other managers and senior specialists. You'll be leading leaders, essentially.
• Matrix relationships: Head of Global Regulatory Affairs, Regulatory Affairs Lead, Compliance Strategy Manager, Associate Director, Regulatory Policy,

Key Stakeholders

Internal:

• SVP of Product Development
• Head of Commercial & Sales
• Legal Counsel (General Counsel)
• Quality Assurance Director
• R&D Leadership Team
• Business Unit General Managers

External:

• Major Health Authorities (e.g., FDA, EMA, MHRA)
• Notified Bodies (for EU market access)
• Industry Trade Associations
• External Legal Counsel & Consultants
• Key Opinion Leaders in Compliance

Organisational Impact

Scope: You're directly responsible for the regulatory success of an entire business unit's product portfolio. This means influencing market entry timelines, ensuring product lifecycle compliance, and protecting the company from significant regulatory risks. Your decisions directly impact revenue generation, market share, and our overall corporate reputation. Frankly, without your team's work, a lot of our products simply wouldn't exist on the market.

Performance Metrics

Quantitative Metrics

1. Metric: Time-to-Market Reduction (Regulatory Phase)
2. Desc: The average time it takes for a new product to clear the regulatory hurdles from submission readiness to market approval.
3. Target: Reduce average time by 15% across the business unit's portfolio.
4. Freq: Quarterly review, annually aggregated.
5. Example: If a typical submission took 12 months, your strategies should aim to bring that down to 10.2 months without compromising quality. We'll track this by comparing actual approval dates against our internal targets and historical averages.
6. Metric: New Market Entry Success Rate
7. Desc: The percentage of targeted new international markets where we successfully gain regulatory approval and launch products within the planned timeframe.
8. Target: Achieve successful entry into 3-5 new target markets per year for your business unit.
9. Freq: Annually.
10. Example: If we target five new countries for a product launch, and you get regulatory approval in four of them on time, that's an 80% success rate. We're looking for consistent, strategic expansion.
11. Metric: Regulatory Audit Findings & Remediation Effectiveness
12. Desc: The number and severity of findings from health authority audits (e.g., FDA, MHRA) and the efficiency of our corrective actions.
13. Target: Zero 'major' or 'critical' findings in health authority audits for your business unit. Close 100% of 'minor' findings within 90 days.
14. Freq: Per audit cycle and quarterly review of CAPA closure rates.
15. Example: After an FDA inspection, if we receive a Form 483 with 3 observations, and your team ensures all are addressed and closed without further escalation, that's a win. We're aiming for 'no major findings' consistently.
16. Metric: Regulatory Intelligence & Horizon Scanning Accuracy
17. Desc: The precision and timeliness of your team's predictions regarding upcoming regulatory changes and their potential impact on our business unit.
18. Target: 90% accuracy in forecasting significant regulatory changes 12-18 months in advance, with a 95% adoption rate of your team's impact assessments by relevant business functions.
19. Freq: Bi-annually against actual regulatory changes and stakeholder feedback.
20. Example: Your team predicts a new EU regulation on digital health devices will impact our software products by Q4 next year. If that regulation indeed comes into force and your impact assessment accurately prepared R&D, that's a hit. We'll track how often your predictions help us avoid surprises.

Qualitative Metrics

1. Metric: Strategic Influence & Proactive Engagement
2. Desc: How effectively you and your team are seen as proactive strategic partners, rather than just a 'Department of No'.
3. Evidence: You're regularly invited to early-stage product strategy meetings. Product and R&D teams seek your input before making key design decisions. Your team's advice is actively sought and shapes business unit strategy, not just reacts to it. You're seen as an enabler, not a blocker.
4. Metric: Team Leadership & Development
5. Desc: The effectiveness of your leadership in mentoring, developing, and retaining a high-performing regulatory team.
6. Evidence: High employee engagement scores within your team (e.g., >80%). Clear succession plans for key roles. Your direct reports are actively seeking and receiving development opportunities. You're known for creating a supportive yet challenging environment where people grow their careers.
7. Metric: Cross-Functional Collaboration & Alignment
8. Desc: How well your team works with other departments to achieve shared goals and ensure regulatory considerations are embedded early.
9. Evidence: Regular, productive meetings with R&D, Quality, and Commercial teams. Joint project successes where regulatory input was critical from the outset. Feedback from other department heads confirms smooth working relationships and effective problem-solving, not just information exchange.
10. Metric: Crisis Management & Issue Resolution
11. Desc: Your ability to lead your team through unexpected regulatory challenges, product issues, or agency inquiries with calm and effective solutions.
12. Evidence: Rapid, well-coordinated responses to urgent regulatory requests or product recalls. Minimal escalation of issues to senior leadership due to your team's effective handling. Post-mortem reviews confirm clear decision-making and efficient resolution processes during critical incidents.

Primary Traits

• Trait: Influential (Not just a rule-follower)
• Manifestation: You're the person who can walk into a room of engineers, product managers, and sales leaders, explain a complex regulatory constraint, and get them to not just understand, but actually buy into the solution. This means persuading an engineering team to adopt a slightly more expensive but significantly more compliant material, or convincing the marketing department to rephrase product claims to drastically reduce regulatory risk. You'll successfully argue for a larger budget based on the potential cost of non-compliance, not just because you 'need' it. Frankly, you're a master at getting people to do the right thing, even when it's inconvenient.
• Benefit: The reality is, regulatory affairs isn't just about knowing the rules; it's about getting a matrixed organisation of engineers, marketers, and operators to follow them, often when it's inconvenient or costly. At this level, you're leading a team that needs to influence entire business units. Without strong influence, you're just a librarian of regulations nobody reads, and that's a recipe for disaster when millions are on the line.
• Trait: Decisive (Under ambiguity)
• Manifestation: You're comfortable making the tough calls when agency guidance is vague or contradictory. This means making a 'go/no-go' decision on a multi-million pound submission even when there's no clear legal precedent. You'll interpret a brand-new regulation, with little to no existing case law, and then create a corporate policy based on your interpretation, knowing you're setting a precedent for the business unit. You might even advise the CEO to pull a product from a specific market based on an evolving political or regulatory risk, backing your judgment with solid reasoning.
• Benefit: Truth is, regulatory affairs rarely has perfect information. At this level, you're dealing with novel situations and high stakes. You must be comfortable making critical decisions based on risk assessment and strategic judgment, knowing you'll be held accountable for the outcome. Indecision here means missed market opportunities or, worse, significant compliance failures.
• Trait: Meticulously Precise (Verging on pedantic)
• Manifestation: You're the one who spots that a date format is 'DD-MM-YYYY' in one section of a 2,000-page submission and 'MM-DD-YYYY' in another, and you insist it gets fixed. You'll catch a subtle but critical difference between the EU and UK versions of the same regulation that others might miss. You'll insist on exact, consistent terminology across all technical documentation and marketing materials because you know the regulators will pick up on any inconsistency. Frankly, your team probably jokes about your attention to detail, but they also know it saves them from major headaches.
• Benefit: A single misplaced comma, an incorrect reference number, or an inconsistent data point in a submission can lead to months of delays, millions in lost revenue, or even outright rejection. For a Director Manager, your team's precision is the bedrock of our credibility with regulators. You're setting the standard here, and that standard needs to be exceptionally high.

Supporting Traits

• Trait: Resilient
• Desc: You and your team will face rejection from agencies, pushback from internal teams, and the constant pressure of changing regulations. The ability to absorb that, learn from it, and move forward with a clear head is absolutely key. You can't take it personally; it's just the job.
• Trait: Diplomatic
• Desc: You'll often be the bearer of bad news—'your project is non-compliant' or 'that market launch is delayed'. You must deliver these messages without alienating the very people you need to fix the problem. It's about finding solutions together, not just pointing fingers.
• Trait: Commercially Astute
• Desc: You need to connect dense, complex regulations to real business outcomes like revenue, market share, and competitive advantage. It's not enough to just know the rules; you need to understand their financial and strategic impact and communicate that clearly to commercial leadership.
• Trait: Mentor & Coach
• Desc: You're leading a team of regulatory professionals, so your ability to develop their skills, provide constructive feedback, and guide their career paths is crucial. You're building the next generation of regulatory leaders.

Primary Motivators

1. Motivator: Strategic Impact & Business Protection
2. Daily: You thrive on seeing your team's strategies directly enable major product launches and protect the company from multi-million pound risks. You'll feel a deep satisfaction when a complex regulatory hurdle is overcome, opening up a new market or ensuring continued sales.
3. Motivator: Solving Complex, Ambiguous Problems
4. Daily: You love diving into brand new regulations with no clear precedent, figuring out what they mean for our business, and then building a clear, actionable plan. The messier the problem, the more engaged you are in finding a compliant solution.
5. Motivator: Developing and Leading High-Performing Teams
6. Daily: You get a real buzz from mentoring your managers and senior specialists, seeing them grow, and empowering them to tackle bigger challenges. Building a cohesive, expert team that consistently delivers is a huge driver for you.

Potential Demotivators

Let's be frank, this role isn't for everyone. If you need absolute clarity and a predictable routine, you'll struggle. The regulatory landscape is a constantly shifting beast, and what was true yesterday might not be true tomorrow. You'll often be the one delivering bad news or pushing back on ambitious commercial plans, and that can be draining if you're not wired for it. If you're looking for a role where every single piece of your team's work makes it to production exactly as planned, you'll be disappointed. The reality is messier than that.

Common Frustrations

1. The 'Last-Minute Checkbox': Being brought into a product development cycle at the very end, only to discover a fundamental design flaw that violates regulations and forces a costly, last-minute redesign. It's infuriating when you could have prevented it months ago.
2. Sales Over-promising: The constant battle with the commercial team who sell features or promise delivery dates in new countries before your team has even started to assess the regulatory pathway. It means you're always playing catch-up.
3. Moving Goalposts: Spending two years developing a product to meet a specific regulation, only for the health authority to publish new 'guidance' three months before launch that changes all the requirements. It feels like the rug is constantly being pulled out from under you.
4. The 'Department of No': Despite all your efforts to be an enabler, you'll still sometimes be seen as a roadblock or a cost center. It's a tough perception to shake when your job is to prevent catastrophic compliance failures.
5. The Black Box Wait: Submitting a multi-million pound product application and then waiting 6, 12, or even 24 months for a response from a government agency with zero visibility into the process or timeline. It's incredibly frustrating and hard to manage business expectations.

What Role Doesn't Offer

1. A predictable, unchanging regulatory environment. It's dynamic, to put it mildly.
2. A role where you're solely focused on individual contribution; leadership and strategic oversight are paramount here.
3. An environment where all internal teams immediately understand and agree with regulatory mandates without persuasion or explanation.
4. A job without high-stakes decisions and the pressure that comes with them.

ADHD Positives

1. The fast-paced, constantly evolving regulatory landscape can be incredibly engaging, offering novel challenges that prevent boredom. You'll be jumping between different strategic problems and team priorities, which can suit a mind that thrives on variety.
2. Your ability to hyperfocus on complex regulatory texts when deeply engaged can be a superpower, allowing you to spot nuances others miss. This is crucial for interpreting new legislation.
3. Often, individuals with ADHD are excellent at 'connecting the dots' between disparate pieces of information, which is invaluable for horizon scanning and impact analysis across different regulations and markets.

ADHD Challenges and Accommodations

1. Managing a large team and multiple strategic initiatives requires strong organisational skills. We can offer tools like advanced project management software (Jira, Asana) and executive assistants to help keep track of priorities and deadlines.
2. The need for meticulous precision can be challenging. We encourage using checklists, templates, and peer review processes to ensure accuracy, and we're happy to discuss specific strategies that work for you.
3. Long, static meetings might be difficult. We aim for shorter, action-oriented meetings and encourage breaks. We're also open to flexible working arrangements that allow for focused work periods.

Dyslexia Positives

1. Often, individuals with dyslexia excel at big-picture strategic thinking and problem-solving, which is exactly what's needed to build global regulatory strategies. You'll be looking beyond the text to the intent and impact.
2. Strong verbal communication and storytelling skills are common, which are vital for influencing stakeholders and simplifying complex 'Reg-lish' for non-experts.
3. You might have an enhanced ability to recognise patterns and spot anomalies in data or trends, which is excellent for horizon scanning and identifying emerging risks.

Dyslexia Challenges and Accommodations

1. Reading and processing dense regulatory documents can be demanding. We provide access to text-to-speech software, screen readers, and tools that can summarise long documents. We also encourage verbal briefings and discussions.
2. Written communication, especially in formal submissions, needs to be precise. We support the use of advanced grammar and spelling checkers, proofreading tools, and dedicated editorial support for critical documents.
3. Organising complex written information can be tough. We use visual tools like mind maps, flowcharts, and collaborative whiteboards (Miro, Mural) for strategy development and team planning.

Autism Positives

1. The deep, analytical thinking required to understand and interpret complex regulatory frameworks can be a significant strength. You'll likely excel at identifying logical inconsistencies or gaps in guidance.
2. A strong adherence to rules and processes, coupled with an exceptional eye for detail, is incredibly valuable in regulatory compliance, where precision is paramount.
3. Your ability to focus intensely on specific regulatory areas and become a subject matter expert is highly valued, especially in niche or emerging compliance fields.

Autism Challenges and Accommodations

1. Navigating complex social dynamics and unspoken expectations in a managerial role can be challenging. We foster a direct, clear communication style and provide training on effective feedback and team leadership.
2. Unexpected changes or shifts in priorities can be difficult. We aim to provide as much advance notice as possible for strategic shifts and have clear processes for managing urgent, unplanned requests.
3. Sensory sensitivities can impact the work environment. We offer options for noise-cancelling headphones, adjustable lighting, and a choice of workspaces (e.g., quiet zones, hybrid work models) to create a comfortable setting.

Key Responsibilities

Experience Levels Responsibilities

1. Level: Principal/Manager (12-16 years)
2. Responsibilities: Set the global regulatory vision and multi-year strategy for an entire business unit's product portfolio. This means looking 3-5 years out, anticipating major shifts, and building the roadmap for how we'll get there. (You're the compass, essentially.)
3. Build and lead a high-performing team of regulatory professionals (10-25 people, including managers). This isn't just about delegating; it's about coaching, mentoring, and ensuring they have the skills and support to deliver. (You're the coach and the talent scout.)
4. Own the business unit's regulatory P&L, managing budgets roughly between £500K and £2M. You'll be accountable for resource allocation, vendor selection, and ensuring we get maximum value from our regulatory investments. (Yes, you're a business leader, not just a compliance expert.)
5. Drive significant organisational change and capability building within your business unit to embed regulatory considerations earlier in the product lifecycle. This might involve transforming existing processes or introducing new ways of working with R&D and Quality. (No more 'Last-Minute Checkbox' if you can help it!)
6. Act as the primary interface with senior executives (SVP, General Managers) and external industry bodies on major regulatory policy issues. You'll represent the organisation's position and influence future regulations. (You're our voice in the room.)
7. Oversee the strategic management of critical regulatory submissions and post-market surveillance activities for your business unit, ensuring a 'no major findings' approach to audits and vigilance reporting. (This is where your team's meticulous precision really shines.)
8. Develop and implement robust change control governance across the business unit, making sure any product or process modification is assessed for regulatory impact before it causes problems. (No more 'This will trigger a CAPA' surprises.)
9. Supervision: You're largely self-directed, with quarterly objectives set in alignment with the Director, International Regulatory Strategy. You'll be expected to operate with significant autonomy, bringing solutions and strategic recommendations rather than just problems.
10. Decision: You have full authority over your functional domain, including budget allocation up to £2M, hiring and firing decisions for your team, and selection of key regulatory vendors (up to roughly £100K per contract). Strategic decisions impacting the broader organisation or requiring significant capital investment will need alignment with the Director and relevant SVPs. Org design within your team is yours to define.
11. Success: Your success will be measured by your ability to consistently deliver on the quantitative and qualitative metrics outlined above, particularly in reducing time-to-market, achieving new market entries, and maintaining a stellar audit record. Beyond that, it's about how effectively you build and lead your team, and how well you embed proactive regulatory thinking across the business unit.

Decision-Making Authority

• Type: Regulatory Strategy & Policy Definition
• Entry: Follows established policies; escalates interpretation questions.
• Mid: Interprets existing policy for routine cases; proposes minor policy adjustments.
• Senior: Develops and recommends new policies for specific projects; makes technical decisions on strategy within workstream.
• Type: Budget Allocation & Resource Management
• Entry: Manages time within assigned tasks; reports on resource usage.
• Mid: Manages project-level budgets (up to £10K); allocates personal time to tasks.
• Senior: Makes recommendations on project budgets (up to £50K); allocates resources within own workstreams.
• Type: Team Leadership & Development
• Entry: Focuses on personal development; seeks feedback.
• Mid: Provides informal guidance to new joiners; identifies personal training needs.
• Senior: Mentors 1-2 junior team members; identifies team skill gaps within projects.
• Type: External Engagement & Representation
• Entry: Supports external meetings (e.g., note-taking); no direct external representation.
• Mid: Communicates with agencies on routine submission queries; participates in agency meetings.
• Senior: Leads specific agency interactions (e.g., pre-submission meetings); represents the company on technical regulatory matters.

Competency Requirements

Foundation Skills (Transferable)

Beyond the technical know-how, this role demands a strong set of foundational skills. You're leading a team and shaping strategy, so your ability to think critically, communicate effectively, and adapt to constant change is paramount. These aren't 'nice-to-haves'; they're essential for success.

• Category: Strategic Leadership & Vision
• Skills: Organisational Design & Development: Building and structuring regulatory teams for optimal effectiveness and future growth.
• Strategic Planning: Developing long-term regulatory roadmaps that align with business objectives and anticipate market shifts.
• Change Management Leadership: Guiding your team and cross-functional partners through significant process and policy changes.
• Risk Management & Mitigation: Identifying, assessing, and proactively mitigating high-level regulatory risks across the business unit.
• Category: Influential Communication & Stakeholder Management
• Skills: Executive Presentation: Clearly articulating complex regulatory issues and strategies to C-suite and board-level audiences.
• Negotiation & Persuasion: Gaining buy-in from diverse internal and external stakeholders on critical compliance initiatives.
• Cross-Functional Collaboration: Building strong working relationships with R&D, Commercial, Legal, and Quality teams to embed regulatory thinking.
• External Representation: Acting as a credible and authoritative voice for the company with health authorities and industry bodies.
• Category: Problem Solving & Decision Making
• Skills: Complex Problem Resolution: Tackling novel regulatory challenges with ambiguous guidance and high stakes.
• Data-Driven Decision Making: Using regulatory intelligence and performance metrics to inform strategic choices.
• Crisis Management: Leading your team through urgent regulatory issues or product recalls with calm and effective solutions.
• Judgment Under Pressure: Making sound decisions when information is incomplete and time is critical.
• Category: Team & Talent Development
• Skills: Mentorship & Coaching: Developing the next generation of regulatory leaders within your team.
• Performance Management: Setting clear expectations, providing constructive feedback, and fostering a culture of accountability.
• Talent Acquisition & Retention: Attracting, hiring, and retaining top regulatory talent.
• Empowerment & Delegation: Effectively delegating responsibility and empowering your team to take ownership.

Functional Skills (Role-Specific Technical)

This is where your deep regulatory expertise really comes into play. You'll need a comprehensive understanding of global regulatory frameworks, coupled with the ability to apply that knowledge strategically and lead your team in using the right tools.

Technical Competencies

• Skill: Regulatory Pathway Assessment (Global)
• Desc: You'll be the ultimate authority on determining the specific type of submission, timeline, and data required to gain market approval in any target country globally. This means understanding the nuances between, say, a 510(k) and a PMA in the US, or CE marking under MDR/IVDR in the EU, and guiding your team through these complex decisions.
• Level: Expert
• Skill: Horizon Scanning & Impact Analysis Leadership
• Desc: You'll oversee and refine the proactive system for monitoring proposed regulations, lobbying efforts, and competitor submissions. Your role is to use this intelligence to forecast long-term regulatory trends and inform multi-year product roadmaps, translating complex data into strategic business insights.
• Level: Expert
• Skill: Gap Analysis & Remediation Planning (Strategic)
• Desc: You'll lead your team in structuring the process of comparing existing product documentation (DHF, DMR), quality processes (QMS), and testing data against the requirements of new or updated regulations. Your goal is to identify systemic shortfalls and direct the creation of comprehensive, cross-functional project plans to close them, often with multi-million pound implications.
• Level: Expert
• Skill: Regulatory Agency Engagement (Executive Level)
• Desc: You'll define and execute the formal and informal communication strategy with major health authorities (e.g., FDA, EMA, MHRA) at an executive level. This includes leading scientific advice meetings, overseeing responses to complex deficiency letters (RTQs), and managing high-stakes pre-submission discussions, often involving C-suite participation.
• Level: Expert
• Skill: Change Control Governance (Organisational)
• Desc: You'll be responsible for establishing and optimising the framework for evaluating any change to a product, process, or supplier across your business unit. This ensures that every modification, no matter how small, is assessed for regulatory notification or submission requirements, preventing costly non-compliances.
• Level: Expert
• Skill: Post-Market Surveillance (PMS) & Vigilance Reporting Leadership
• Desc: You'll oversee the systematic process of monitoring a device's real-world performance, collecting user feedback, and ensuring fulfilment of mandatory incident reporting requirements to regulatory authorities within strict deadlines. This includes strategic oversight of health hazard evaluations and field safety corrective actions.
• Level: Expert

Digital Tools

• Tool: ServiceNow GRC / Veeva Vault (QualityDocs/Submissions)
• Level: Strategic
• Usage: Leading the selection, implementation, and strategic integration of GRC/QMS platforms with other enterprise systems (e.g., SAP S/4HANA). You'll define how these tools support our global regulatory strategy and ensure data integrity across the business unit.
• Tool: Enhesa / RegScan / Thomson Reuters Regulatory Intelligence
• Level: Strategic
• Usage: Using intelligence data from these platforms to forecast long-term regulatory trends, identify emerging risks, and inform multi-year product roadmaps and market entry strategies for your business unit. You'll ensure your team is extracting maximum strategic value.
• Tool: Lorenz docuBridge / eCTD Express / Adobe Acrobat Pro (with compliance plugins)
• Level: Architect
• Usage: Setting the organisation's publishing standards and templates for all regulatory submissions. You'll evaluate and select new publishing tools, ensuring they meet global agency requirements and optimise the efficiency of your team's submission processes.
• Tool: MS Teams (with SharePoint integration) / Jira / Confluence
• Level: Strategic
• Usage: Mandating and standardising tool usage across cross-functional teams to ensure a single source of truth for all regulatory activities within your business unit. You'll architect how these tools support collaboration and knowledge management for global regulatory projects.
• Tool: Power BI / Tableau Server / Diligent Boards
• Level: Strategic
• Usage: Presenting interactive dashboards to the C-suite and using platforms like Diligent to prepare board-level compliance reports. You'll define the key regulatory performance indicators (KPIs) and ensure they are accurately tracked and communicated to senior leadership.

Industry Knowledge

• Area: Global Regulatory Frameworks (e.g., EU MDR/IVDR, FDA QSR, Health Canada, TGA, PMDA)
• Desc: Deep, expert-level understanding of the regulatory requirements in all major global markets relevant to our product portfolio, including specific nuances and emerging trends in each region. You'll be expected to guide your team through these complexities.
• Area: Quality Management Systems (QMS) & ISO Standards (e.g., ISO 13485)
• Desc: Comprehensive knowledge of QMS principles and international standards, understanding how regulatory compliance integrates with and relies upon a robust quality system. You'll drive QMS improvements from a regulatory perspective.
• Area: Product Lifecycle Management (PLM) from a Regulatory Perspective
• Desc: Expertise in integrating regulatory strategy across the entire product lifecycle, from R&D and design control through manufacturing, post-market surveillance, and eventual product discontinuation. You'll ensure regulatory considerations are embedded at every stage.
• Area: Digital Health & Software as a Medical Device (SaMD) Regulations
• Desc: Specialised knowledge of the rapidly evolving regulatory landscape for digital health products, including software validation, cybersecurity, and data privacy requirements (e.g., GDPR, HIPAA). This is a critical growth area.

Regulatory Compliance Regulations

• Reg: EU Medical Device Regulation (MDR) & In Vitro Diagnostic Regulation (IVDR)
• Usage: You'll be the ultimate authority on our compliance with MDR/IVDR, leading strategic remediation efforts, managing Notified Body relationships, and ensuring our products maintain CE marking. This includes overseeing clinical evaluation, PMS, and technical documentation.
• Reg: US FDA Quality System Regulation (QSR) & Device Classification (21 CFR Part 820)
• Usage: You'll ensure our QMS is fully compliant with FDA QSR, overseeing audit readiness, CAPA management, and the strategic approach to device classification (e.g., 510(k), PMA, De Novo) for US market access. You'll lead responses to FDA 483s.
• Reg: UK MHRA Regulations (Post-Brexit)
• Usage: You'll navigate the post-Brexit regulatory landscape for the UK market, ensuring compliance with MHRA requirements, UKCA marking, and any specific UK-only guidance. This involves strategic planning for parallel submissions and market authorisations.
• Reg: APAC & LATAM Regional Regulations (e.g., TGA, PMDA, ANVISA)
• Usage: You'll oversee the strategic approach to market entry and compliance in key APAC and LATAM regions, guiding your team on specific country requirements, local representation, and submission strategies. You'll identify and mitigate regional regulatory risks.

Essential Prerequisites

• Proven experience (at least 5 years) leading and managing a team of regulatory professionals, including performance management and talent development.
• Demonstrable track record of developing and implementing successful global regulatory strategies for complex product portfolios.
• Extensive hands-on experience with major health authority interactions (e.g., leading scientific advice meetings, responding to major audit findings, managing high-stakes submissions).
• Deep understanding of Quality Management Systems (QMS) and their integration with regulatory compliance, ideally in a medical device or pharmaceutical context.
• Strong commercial acumen, with the ability to translate regulatory requirements into business impact and influence commercial decisions.
• Expert-level knowledge of at least two major global regulatory frameworks (e.g., EU MDR/IVDR and US FDA regulations) and a working knowledge of others.

Career Pathway Context

To thrive in this Director Manager role, you'll need to have moved beyond just managing projects to managing people and strategic functions. We're looking for someone who has already demonstrated the ability to lead, influence, and make high-stakes decisions under pressure. This isn't a first-time management role; it's for someone ready to step up and own a significant piece of our global regulatory puzzle.

Qualifications & Credentials

Emerging Foundation Skills

• Skill: Advanced Geopolitical & Trade Policy Risk Analysis
• Why: Global trade tensions, shifting political alliances, and the increasing weaponisation of regulatory compliance mean that regulatory strategy can no longer be divorced from geopolitics. Brexit was just the start; expect more regionalisation and protectionism.
• Concepts: [{'concept_name': 'Impact of trade agreements (or lack thereof) on re', 'description': 'Impact of trade agreements (or lack thereof) on regulatory harmonisation'}, {'concept_name': "Understanding 'regulatory sovereignty' and its imp", 'description': "Understanding 'regulatory sovereignty' and its implications for global market access"}, {'concept_name': 'Scenario planning for geopolitical disruptions (e.', 'description': 'Scenario planning for geopolitical disruptions (e.g., supply chain, market access)'}, {'concept_name': 'Analysing the influence of national security conce', 'description': 'Analysing the influence of national security concerns on product approvals'}, {'concept_name': 'Navigating sanctions and export control regulation', 'description': 'Navigating sanctions and export control regulations from a compliance perspective'}]
• Prepare: This quarter: Subscribe to geopolitical risk analysis newsletters (e.g., Eurasia Group, Stratfor).
• Next quarter: Attend a webinar or course on international trade policy and its impact on regulatory affairs.
• Month 6: Lead a scenario planning exercise with your team on a hypothetical geopolitical event affecting a key market.
• Month 9: Develop a 'geopolitical risk dashboard' for your business unit's regulatory strategy.
• QuickWin: Start incorporating a 'geopolitical impact' section into your team's horizon scanning reports today. It's a simple addition that forces a broader perspective.
• Skill: Ethical AI & Algorithmic Transparency in Compliance
• Why: As we and regulators increasingly use AI in product development, quality control, and even regulatory submissions, the ethical implications and the need for algorithmic transparency will become paramount. Regulators are already drafting guidelines, and we need to be ready.
• Concepts: [{'concept_name': 'AI Act (EU) and similar global frameworks for AI g', 'description': 'AI Act (EU) and similar global frameworks for AI governance'}, {'concept_name': 'Explainable AI (XAI) principles for regulatory sub', 'description': 'Explainable AI (XAI) principles for regulatory submissions'}, {'concept_name': 'Bias detection and mitigation in AI-driven complia', 'description': 'Bias detection and mitigation in AI-driven compliance tools'}, {'concept_name': 'Data privacy and security considerations for AI in', 'description': 'Data privacy and security considerations for AI in regulatory data'}, {'concept_name': 'Ethical review processes for AI-enabled products a', 'description': 'Ethical review processes for AI-enabled products and internal tools'}]
• Prepare: This quarter: Read the EU AI Act proposal and relevant industry guidance.
• Next quarter: Work with our internal AI/Data Science team to understand their models and data sources.
• Month 6: Develop an internal 'AI ethics checklist' for regulatory submissions and product development.
• Month 9: Lead a training session for your team on the regulatory implications of AI in our products.
• QuickWin: Start asking 'How was this AI trained?' and 'What data did it use?' whenever you encounter an AI-generated output. It builds critical thinking.

Advancing Technical Skills

• Skill: Digital Health & Software as a Medical Device (SaMD) Regulatory Expertise
• Why: The convergence of healthcare and technology is accelerating. Software-driven products, apps, and AI diagnostics are becoming mainstream, but their regulatory pathways are still evolving. This is a massive growth area for us, and we need to be at the forefront.
• Concepts: [{'concept_name': 'SaMD classification and pre-market requirements (e', 'description': 'SaMD classification and pre-market requirements (e.g., IEC 62304, ISO 82304-2)'}, {'concept_name': 'Cybersecurity regulations for medical devices (e.g', 'description': 'Cybersecurity regulations for medical devices (e.g., FDA guidance, EU MDR Annex I)'}, {'concept_name': 'Data privacy frameworks (GDPR, HIPAA, CCPA) in a d', 'description': 'Data privacy frameworks (GDPR, HIPAA, CCPA) in a digital health context'}, {'concept_name': 'Regulatory considerations for AI/ML in SaMD (e.g.,', 'description': "Regulatory considerations for AI/ML in SaMD (e.g., 'locked' vs. 'adaptive' algorithms)"}, {'concept_name': 'Real-world evidence (RWE) and digital clinical tri', 'description': 'Real-world evidence (RWE) and digital clinical trials for regulatory submissions'}]
• Prepare: This quarter: Deep dive into the latest FDA guidance on SaMD and AI/ML in medical devices.
• Next quarter: Identify a key digital health product in our pipeline and lead its regulatory strategy development.
• Month 6: Engage with industry working groups focused on digital health regulations.
• Month 9: Develop a comprehensive internal training module for your team on SaMD regulatory pathways.
• QuickWin: Review the regulatory status of one of our existing software products and identify any emerging compliance gaps. It's practical and immediate.
• Skill: Predictive Regulatory Modelling & Advanced Analytics
• Why: Moving beyond reactive compliance, the future of regulatory strategy involves using data to predict outcomes. This means building models to forecast agency review times, predict the likelihood of audit findings, or even optimise submission content for faster approval. It's about turning regulatory data into a strategic asset.
• Concepts: [{'concept_name': 'Statistical methods for predicting regulatory time', 'description': 'Statistical methods for predicting regulatory timelines and outcomes'}, {'concept_name': 'Data visualisation techniques for communicating co', 'description': 'Data visualisation techniques for communicating complex regulatory insights'}, {'concept_name': 'Machine learning applications for identifying patt', 'description': 'Machine learning applications for identifying patterns in agency feedback'}, {'concept_name': 'Building and validating predictive models using hi', 'description': 'Building and validating predictive models using historical submission data'}, {'concept_name': 'Ethical considerations and bias in predictive regu', 'description': 'Ethical considerations and bias in predictive regulatory analytics'}]
• Prepare: This quarter: Partner with our Data Science team to explore existing regulatory data sets.
• Next quarter: Identify one specific regulatory process where predictive modelling could offer a tangible benefit.
• Month 6: Lead a pilot project to build a simple predictive model for agency response times.
• Month 9: Present findings and a proposal for broader implementation of predictive analytics in your business unit.
• QuickWin: Start by simply tracking and visualising your team's submission data more rigorously. Look for trends in agency questions or common deficiencies. You can't predict without good data.

Education Requirements

• Level: Minimum
• Req: A Bachelor's degree in a relevant scientific, engineering, legal, or health-related discipline.
• Alts: We're open to candidates with exceptional, demonstrable experience (15+ years) in a senior regulatory leadership role that clearly showcases equivalent knowledge and strategic capability, even without a degree. We value what you can do, not just where you studied.
• Level: Preferred
• Req: A Master's degree (MSc, MBA, LLM) or a PhD in a relevant scientific or legal field.
• Alts: A strong track record of published articles, industry presentations, or significant contributions to regulatory policy development can also be highly advantageous.

Experience Requirements

You'll need at least 12-16 years of progressive experience in regulatory affairs, with a significant portion (minimum 5-7 years) in a leadership role managing teams of regulatory professionals. This should include direct experience in developing and implementing international regulatory strategies for complex product portfolios, ideally within the medical device, pharmaceutical, or digital health sectors. We're looking for someone who has navigated multiple product launches across diverse global markets and handled high-stakes interactions with major health authorities.

Preferred Certifications

• Cert: Regulatory Affairs Certification (RAC)
• Prod: Regulatory Affairs Professionals Society (RAPS)
• Usage: This is the gold standard for regulatory professionals. It demonstrates a comprehensive understanding of regulatory requirements in either the US or EU, and often both. It tells us you're serious about your craft.
• Cert: Certified Quality Auditor (CQA) or Certified Quality Manager (CQM)
• Prod: American Society for Quality (ASQ)
• Usage: Given the close link between regulatory compliance and quality systems, these certifications show you understand the underlying quality principles that underpin successful regulatory strategies and audit readiness.
• Cert: Project Management Professional (PMP)
• Prod: Project Management Institute (PMI)
• Usage: While not directly regulatory, managing complex global regulatory programmes requires exceptional project management skills. A PMP demonstrates your ability to lead and deliver complex initiatives on time and within budget.

Recommended Activities

• Active participation and leadership roles in industry trade associations (e.g., MedTech Europe, AdvaMed, ABHI).
• Regular attendance at major international regulatory conferences and workshops (e.g., RAPS Regulatory Convergence, DIA Annual Meeting).
• Continuous learning through online courses, webinars, and publications on emerging regulatory trends, digital health, and AI in compliance.
• Mentoring junior regulatory professionals, either formally or informally, to give back to the community and hone your leadership skills.
• Contributing to thought leadership through articles, presentations, or white papers on key regulatory topics.

Career Progression Pathways

Entry Paths to This Role

• Path: Senior Regulatory Affairs Manager (from another company)
• Time: You'd typically spend 3-5 years in a similar senior manager role, perhaps overseeing a smaller portfolio or a specific region, before stepping into this broader Director Manager position. You'd be looking for a bigger scope and more strategic impact.
• Path: Principal Regulatory Strategist (internal promotion)
• Time: If you're already a Principal Strategist here, you'd likely spend 4-6 years mastering complex, novel regulatory challenges and acting as a subject matter expert before stepping into a people leadership role like this. You'd need to show you can lead, not just advise.
• Path: Legal Counsel (with regulatory specialisation)
• Time: Some candidates transition from a legal background, having spent 10-15 years as a regulatory lawyer in a firm or in-house, specialising in compliance for our industry. The shift is usually driven by a desire for more direct business impact and strategic ownership.

Career Progression From This Role

• Pathway: Director, International Regulatory Strategy (Level 006)
• Time: Roughly 3-5 years in this Director Manager role, consistently delivering strong results and demonstrating readiness for broader scope.

Long Term Vision Potential Roles

• Title: VP / Chief Regulatory & Compliance Officer (Level 007)
• Time: 7-10+ years from this Director Manager role.
• Title: Head of Quality & Regulatory Affairs
• Time: 5-8 years from this Director Manager role.
• Title: Chief Product Officer (CPO) / Head of Product Development
• Time: 8-12 years from this Director Manager role (less common, but possible).

How Zavmo Delivers This Role's Development

DISCOVER Phase: Skills Gap Analysis

Zavmo maps your current competencies against all requirements in this job description through conversational assessment. We evaluate your foundation skills (communication, strategic thinking), functional skills (CRM expertise, negotiation), and readiness for career progression.

Output: Personalised skills gap heat map showing strengths and priorities, estimated time to competency, neurodiversity accommodations.

DISCUSS Phase: Personalised Learning Pathway

Based on your DISCOVER results, Zavmo creates a personalised learning plan prioritised by impact: foundation skills first, then functional skills. We adapt to your learning style, pace, and neurodiversity needs (ADHD, dyslexia, autism).

Output: Week-by-week schedule, each module linked to specific job responsibilities, checkpoints and milestones.

DELIVER Phase: Conversational Learning

Learn through conversation, not boring modules. Zavmo uses 10 conversation types (Socratic dialogue, role-play, coaching, case studies) to build competence. Practice difficult QBR presentations, negotiate tough renewals, and handle churn conversations in a safe AI environment before facing real clients.

Example: "For 'Stakeholder Mapping', Zavmo will guide you through analysing a complex enterprise account, identifying key decision-makers, and building an engagement strategy."

DEMONSTRATE Phase: Competency Assessment

Zavmo automatically builds your evidence portfolio as you learn. Every conversation, practice scenario, and application example is captured and mapped to NOS performance criteria. When ready, your portfolio supports OFQUAL qualification claims and demonstrates competence to employers.

Output: Competency matrix, evidence portfolio (downloadable), qualification readiness, career progression score.