The Mullings Group · 1 day ago
Vice President of Regulatory and Quality
United States
Full-time
Remote
Director/Executive
15+ years expThe Mullings Group is a high-growth surgical robotics company backed by top-tier investors, seeking a Vice President of Regulatory Affairs & Quality to lead global regulatory strategy and compliance. This hands-on executive role involves building regulatory infrastructure while navigating FDA, EU MDR, ISO 13485, and Health Canada requirements.
Medical DeviceHealthcareHealth CareMedical
Hiring Manager
Jeremy Peck
Responsibilities
Own global regulatory strategy and execute 510(k), PMA supplements, EU MDR technical files, and international registrations
Serve as the primary interface with the FDA, notified bodies, and regulatory authorities
Oversee Quality Management System (QMS) aligned with FDA QSR, ISO 13485, and EU MDR
Partner with R&D and Clinical teams to define regulatory pathways for new product launches
Lead manufacturing transfer activities, ensuring regulatory and quality continuity
Drive post-market surveillance, CAPA oversight, and vigilance reporting
Qualification
Required
15+ years in Regulatory Affairs and Quality within medical devices with strategic leadership experience
Proven success leading 510(k), PMA, and EU MDR submissions
Deep expertise in FDA QSR, ISO 13485, EU MDR; familiarity with FDA QMSR (2026+) strongly preferred
Experience with capital equipment AND disposable medical devices
Track record building/scaling regulatory functions in growth-stage or carve-out environments
Bachelor's degree in engineering or life sciences required
Preferred
advanced degree preferred
Company
The Mullings Group
The Mullings Group is a search firm specializing in the medical device market.
11-50 employees
Funding
Current Stage
Early StageLeadership Team
Kirk Petyo
Executive Vice President
Emily Phair
Senior Partner
Recent News
The Mullings Group
2025-08-28
Canada NewsWire
2022-12-23
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