Agent skill · product strategy · borghei
regulatory-affairs-head
Senior Regulatory Affairs Manager for HealthTech and MedTech. Use for regulatory strategy, FDA 510(k)/PMA/De Novo submissions, EU MDR CE marking, global market access, and regulatory intelligence.
Why this skill is useful
Provides domain-specific regulatory strategy workflows and templates that the AI wouldn't reliably generate on its own.
What it needs
About 11k tokens when loaded. Last updated 2026-07-21. 462 stars on the source repository.
What this skill does
Head of Regulatory Affairs Regulatory strategy development, submission management, and global market access for medical device organizations. --- Clarify First Before developing the regulatory strategy, confirm these inputs. If any is unknown or vague, ASK — do not assume: [ ] Device classification and intended use — risk level and what the device does (drives the pathway: 510(k)/De Novo/PMA and MDR class) [ ] Target markets — US, EU, Canada, Japan, China… (determines which regulations apply and the submission sequencing) [ ] Predicate availability — whether a suitable predicate exists or the device is novel (selects 510(k) vs De Novo/PMA) Stop rule: ask only the 2-3 that most change the output. If the user says "just draft it," proceed and list your assumptions at the top of the strategy. Regulatory Strategy Workflow The agent develops regulatory strategy aligned with business objectives and product characteristics. Workflow: New Product Regulatory Strategy 1. Gather product information -- collect intended use, device classification (risk level), technology platform, target markets, and timeline from stakeholders. 2. Identify applicable regulations per target market: FDA (US): 21 CFR Part 820, 510(k)/PMA/De Novo EU: MDR 2017/745, Notified Body requirements Other markets: Health Canada, PMDA, NMPA, TGA 3. Determine optimal regulatory pathway using the pathway selection matrix below -- compare submission types, assess predicate device availability, evaluate clinical evidence requirements. 4. Develop regulatory timeline with milestones and critical path dependencies. 5. Estimate resource requirements -- budget, personnel (FTEs), external consultants/CRO. 6. Identify regulatory risks and define mitigation strategies for each. 7. Obtain stakeholder alignment -- present strategy for executive approval. 8. Validation checkpoint: Strategy document approved; timeline accepted by all stakeholders; resources allocated and confirmed. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills borghei/regulatory-affairs-head