Senior Manager, Regulatory Affairs (MedTech)
Core
Senior individual contributor responsible for regulatory decision-making and strategy for complex or high-risk MedTech products and regions.
Role type
Senior Manager, Regulatory Affairs (MedTech)
Builds
Regulatory strategies and submissions for complex, high-risk medical devices and therapies
Domain
Medical Technology / Healthcare
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Regulatory strategy execution, U.S. and international submission preparation (510(k)/NDA), lifecycle compliance management, Health Authority negotiation, post-market surveillance reporting, product labeling review, cross-functional technical leadership
Preferred skills
Experience with infusion systems, transfusion technologies, cellular therapies, or drugs
Technologies
510(k), NDA Supplements, PADERs, PSURs, PMS/PMCF reports
Responsibilities
Own regulatory decision-making and strategy for assigned product lines; prepare and oversee complex regulatory submissions; approve strategies developed by junior managers; represent Regulatory Affairs as the senior lead on cross-functional teams; monitor evolving regulatory requirements and assess impact; review and approve product labeling and promotional materials; lead interactions with Health Authorities; ensure post-market compliance; mentor regulatory team members
Seniority
Senior Manager, hands-on IC with strategic oversight