Agent skill · product strategy · davila7
regulatory-affairs-head
Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies. Provides strategic regulatory guidance, submission management, regulatory pathway analysis, global compliance coordination, and cross-functional team leadership. Use for regulatory strategy development, submission planning, regulatory risk assessment, and team coordination activities.
Why this skill is useful
Provides domain-specific regulatory strategy frameworks and submission management processes that the AI wouldn't reliably generate on its own.
What it needs
About 2k tokens when loaded. Last updated 2026-08-06. 30,138 stars on the source repository.
What this skill does
Senior Regulatory Affairs Manager (Head of Regulatory Affairs) Expert-level regulatory affairs leadership for HealthTech and MedTech companies with deep knowledge of global regulatory frameworks, submission strategies, and cross-functional team coordination. Core Competencies 1. Strategic Regulatory Planning Develop comprehensive regulatory strategies that align with business objectives and ensure successful market access. Key Activities: Regulatory pathway analysis and optimization Market access timeline development Resource allocation and budget planning Competitive regulatory landscape analysis 2. Regulatory Submission Management Lead all aspects of regulatory submissions from pre-submission through post-market surveillance. Submission Workflow: 1. Pre-submission Strategy Conduct regulatory authority consultations Define submission scope and timeline Decision Point: Choose optimal submission pathway (De Novo, 510(k), PMA, MDR CE, etc.) 2. Submission Preparation For EU MDR: Follow references/eu-mdr-submission-guide.md For FDA: Follow references/fda-submission-guide.md For ISO Requirements: Follow references/iso-regulatory-requirements.md For Global Markets: Follow references/global-regulatory-pathways.md 3. Submission Review and Approval Manage regulatory authority communications Coordinate responses to regulatory questions Monitor approval timelines and dependencies 3. Cross-functional Team Leadership Coordinate regulatory activities across all departments ensuring alignment and compliance. Team Coordination Protocol: Weekly: Regulatory team meetings and cross-functional updates Monthly: Regulatory committee meetings for strategic planning Quarterly: Regulatory training and compliance assessments Handoff Requirements: Clear documentation for all team interactions 4. Risk Assessment and Mitigation Identify, assess, and mitigate regulatory risks throughout the product lifecycle. …
How to use it
Reference it in AdaL, Claude Code, Cursor or any coding agent — nothing to install:
@skills davila7/regulatory-affairs-head