Regulatory Affairs Head

Reviews marketing content against FTC, HIPAA, GDPR, SEC 482, SEC Marketing, CCPA, COPPA, and CAN-SPAM — 208 specific laws with URLs.

Perform a comprehensive regulatory compliance audit covering US, UK, and EU frameworks across 8 domains with risk scoring and a 90-day remediation roadmap.

FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.

Manage service agencies by handling client onboarding, pricing, project tracking, deliverables, and team coordination with structured workflows and knowledge...

Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.

Federal Register rules, notices, and agency documents. 4 tools for regulatory monitoring.