The scoreboard, honestly: the hard targets, how often each one is actually looked at,
and the quiet human signals that never make it onto a dashboard.
First-Pass Approval Rate on Submissions
The percentage of major regulatory submissions (e.g., CE Mark, 510(k), PMDA approvals) that get approved without needing significant additional information requests or resubmissions.
Target · >85%If you submit 10 major dossiers in a quarter and 9 are approved without needing a 'Request for Information' (RFI) that delays approval, that's a 90% first-pass rate. We're aiming high here because delays cost serious money.
Average Time to Market (Regulatory Phase)
The average time it takes from your team's 'submission ready' sign-off to receiving the final regulatory approval for a new product or market entry.
Target · Reduce by 10% year-on-yearIf a typical approval used to take 12 months, we want to see that drop to around 10.8 months. This isn't just about speed; it's about anticipating agency questions and building a rock-solid submission from the start.
Regulatory Project Deadline Adherence
The percentage of critical regulatory project milestones (e.g., submission dates, response deadlines to agency queries) that are met on or before the planned date.
Target · >95%If a health authority gives us 30 days to respond to a deficiency letter, you'll need to make sure that response is drafted, reviewed, and submitted within that window. Missing these can mean starting over or worse.
Impact Analysis Accuracy
How accurately you predict the operational and financial impact of new or changing regulations on our product portfolio and business operations.
Target · Within ±15% of actual impactIf you predict a new regulation will require £50K in re-testing and 3 months of delay, and the actual cost is £55K and 3.5 months, you're well within target. It's about giving the business a realistic heads-up.
Proactive Regulatory Counsel
Your ability to spot potential regulatory issues before they become actual problems and offer practical, business-minded solutions, rather than just pointing out the rules.
- Product teams consistently bring you in early for design reviews. You're invited to strategic planning sessions for new market entries. You're seen as a problem-solver, not just a gatekeeper. Colleagues say things like, 'You always know what's coming next with the regulators.'
Internal Influence & Collaboration
How effectively you get different internal teams (like R&D, Marketing, Quality) to understand and follow regulatory requirements, even when it's inconvenient for them. It's about getting everyone on the same page without always having to pull rank.
- You successfully persuade an engineering team to make a design change for compliance without major friction. Marketing consistently seeks your approval for claims before campaigns launch. Teams willingly adopt your recommended processes. People actually listen when you talk about 'Reg-lish'.
Quality of Mentorship
The effectiveness of your guidance and support for junior team members, helping them develop their skills and navigate complex regulatory challenges.
- Junior team members consistently seek your advice. Their work quality noticeably improves under your guidance. They feel supported and empowered to take on more complex tasks. They're actually asking good questions about 'predicate devices' now.
Clarity of Communication (Internal & External)
Your ability to translate complex regulatory jargon into clear, concise, and actionable language for internal business teams, and to communicate effectively and credibly with health authorities.
- Executive summaries of regulatory changes are clear and actionable. Agency correspondence is precise and well-received. You can explain 'Substantial Equivalence' to a sales manager without their eyes glazing over. Feedback from internal teams often highlights your ability to simplify complex topics.