{"slug":"alirezarezvani-regulatory-affairs-head","source_name":"alirezarezvani/regulatory-affairs-head","name":"Alirezarezvani/Regulatory Affairs Head","description":"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 pl","version":1,"lift":{"pass_rate_delta_pts":25,"pass_rate_pct":62.5,"total_cases":24,"passed_cases":15,"tokens_delta_pct":168.8,"turns_delta_pct":0,"verdict":"mixed","benchmark_model":"gemini-3.6-flash","grading_method":"judged","completed_at":"2026-08-10T06:12:59.115067+00:00"},"skill_score":0.625,"benchmark_models":[{"model":"gemini-3.6-flash","headline":true,"delta_pts":25,"with_pass_pct":62.5,"without_pass_pct":37.5,"tokens_delta_pct":168.8,"turns_delta_pct":0,"total_cases":24,"cases_aggregated":24,"verdict":"mixed","never_hurt":true,"completed_at":"2026-08-10T06:12:59.115067+00:00","run_id":"eef818d3-d6d8-4ae7-b540-3a0ab66c997c","version_number":1,"is_latest_version":true,"gate":null}],"trust":{"skill_safety":"passed","safety_status":"clean","intent_verdict":"safe","content_status":"clean","indexable":true},"license":"MIT","install_count":0,"manifest_hash":"796f07ff467a75448d7d2a891e9cf6777d6e98ac389d72f453c947197defc97a","raw_url":"https://app.decimal.ai/s/alirezarezvani-regulatory-affairs-head/SKILL.md","scorecard_url":"https://app.decimal.ai/skills/alirezarezvani-regulatory-affairs-head"}