regulatory-affairs-head

Regulatory strategy development, submission management, and global market access for medical device organizations. Develop regulatory strategy aligned with business objectives and product characteristics. Prepare and submit FDA regulatory applications. See: references/fda-submission-guide.md Achieve CE marking under EU MDR 2017/745. See: references/eu-mdr-submission-guide.md Coordinate regulatory approvals across international markets. See: references/global-regulatory-pathways.md Monitor and respond to regulatory changes affecting product portfolio. Regulatory Tracker Features: - Regulatory Strategy Workflow - FDA Submission Workflow - EU MDR Submission Workflow - Global Market Access Workflow - Regulatory Intelligence Workflow - Decision Frameworks - Tools and References - Gather product information: - Intended use and indications - Device classification (risk level) - Technology platform - Target markets and timeline - 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 - Determine optimal regulatory pathway: - Compare submission types (510(k) vs De Novo vs PMA) - Assess predicate device availability - Evaluate clinical evidence requirements - Develop regulatory timeline with milestones - Estimate resource requirements and budget -...