Head of Regulatory Affairs

Regulatory strategy development, submission management, and global market access for medical device organizations.

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.