regulatory-affairs-head

7.5

123

310

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.

regulatory

7.5

Rating

Installs

Business & Productivity

Quick Review

Strong skill for regulatory affairs leadership in HealthTech/MedTech. The description clearly defines when to invoke the skill (regulatory strategy, submissions, risk assessment, team coordination). SKILL.md provides comprehensive frameworks, decision trees, and submission workflows with clear references to detailed guides (EU MDR, FDA, ISO, global pathways). Structure is excellent with logical organization, clear handoffs to reference files, and appropriate overview-to-detail balance. Task knowledge is robust with actionable protocols, KPI frameworks, and scripts for tracking/compliance. Novelty is moderate - while valuable for consolidating complex regulatory knowledge and reducing research time, some aspects (checklists, templates, basic guidance) could be handled by a capable CLI agent with sufficient tokens, though the integrated strategic frameworks and cross-functional coordination protocols add meaningful value beyond simple information retrieval.