Vice President, Quality Assurance & Regulatory Affairs

About the role

The Vice President of Quality Assurance & Regulatory Affairs is a key leadership role responsible for shaping and executing Mobia Medical's global quality and regulatory strategy. Reporting to the Chief Operating Officer, this leader will oversee the company's Quality Management System (QMS), global regulatory affairs, compliance initiatives with ISO 13485 and FDA 21 CFR Part 820 systems, and product approval strategies to support the continued growth of the Vivistim® platform.

This role partners closely with Clinical, R&D, Operations, Legal, and Executive Leadership to ensure quality and regulatory excellence is embedded throughout the product lifecycle—from development through commercialization and post-market surveillance. As the Person Responsible for Regulatory Compliance (PRRC-MDR), the VP will lead a global quality and regulatory organization while helping Mobia Medical for continued international expansion and innovation.

Qualifications

• Bachelor's degree in a scientific, engineering, or other technical discipline.
• 15+ years of progressive leadership experience in Quality Assurance and Regulatory Affairs within the medical device industry.
• Deep expertise supporting Class II and/or Class III medical devices; experience with active implantable medical devices is strongly preferred.
• Extensive knowledge of FDA regulations, ISO 13485, ISO 14971, EU MDR, and FDA 21 CFR Parts 801, 803, 806, and 820.
• Demonstrated success leading FDA inspections, international regulatory submissions, and global quality management systems.
• Proven experience building, mentoring, and leading high-performing quality and regulatory organizations.
• Exceptional leadership, communication, and cross-functional collaboration skills with the ability to influence executive stakeholders.
• Strong organizational, project management, and strategic planning capabilities.

Preferred Qualifications

• Regulatory Affairs Certification (RAC), American Society for Quality (ASQ) certification, or similar professional credentials.
• Experience serving as a Person Responsible for Regulatory Compliance (PRRC) under EU MDR.
• Experience supporting commercial-stage, high-growth medical device organizations.
• Demonstrated success developing global regulatory strategies for innovative implantable medical technologies.
• Ability to thrive in a fast-paced, collaborative environment while driving continuous improvement and organizational excellence.

Benefits

Mobia Medical provides a comprehensive benefits program to employees. It includes medical, dental and vision plans along with an FSA. Employees may participate in the company 401(k) plan with company matching. The company offers an unlimited Paid Time Off (PTO) program and approximately 18 paid company holidays per year.