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regulatory-affairs-head v1
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017/745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.
d28fa2ec167b423a476eeb0cae54fc3d3a1a47be374333e39fd2d3070e82d4b1Package contents
Manifest
Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017/745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.
b0af2bc46d0c8cd8c4989547bf9496e4c104505c5f18d07b2d8ba7c36e6014de- SKILL.md20,232 bytes
- references/eu-mdr-submission-guide.md3,272 bytes
- references/fda-submission-guide.md4,442 bytes
- references/global-regulatory-pathways.md9,806 bytes
- references/iso-regulatory-requirements.md14,171 bytes
- scripts/regulatory_pathway_analyzer.py23,077 bytes
- scripts/regulatory_tracker.py8,223 bytes