Sr Manager, Regulatory Affairs
Core
Leads global regulatory strategy and compliance for Merge Healthcare's medical imaging portfolio, including Software as a Medical Device (SaMD), ensuring market access and adherence to international regulations.
Role type
Senior Manager, Regulatory Affairs (Medical Devices/SaMD)
Builds
Global regulatory strategies, market authorization packages, and compliance programs for enterprise imaging solutions.
Domain
Healthcare Technology / Medical Imaging / Software as a Medical Device (SaMD)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Global medical device regulatory frameworks (FDA, EU MDR, MDSAP), SaMD lifecycle management, regulatory submission preparation, risk-based decision making, team leadership, cross-functional collaboration
Preferred skills
AI/ML-enabled medical device guidance, cybersecurity expectations for connected devices, Regulatory Affairs Certification (RAC), building high-performing teams
Technologies
FDA QSR/QMSR, ISO13485, IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, MDSAP, EU MDR
Responsibilities
Lead and mentor a high-performing regulatory team; develop and maintain global regulatory strategies for market access; oversee global product registrations and market authorizations; evaluate product modifications for regulatory impact; serve as primary liaison with regulatory authorities and notified bodies; monitor regulatory changes and ensure timely implementation; drive continuous improvement of regulatory and quality processes.
Seniority
Senior Manager, 10+ years experience, direct people management