Vice President, Quality Assurance & Regulatory Affairs

Mobia Medical•Fridley, MN

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

Provide strategic leadership for Mobia Medical's global Quality Assurance and Regulatory Affairs functions. Anticipate scope and scale changes with growth of the company, and plan and ensure suitable growth in the capability and capacity of the function.
Develop, maintain, and continuously improve the company's Quality Management System (QMS) to ensure compliance with FDA regulations, ISO 13485, cGMPs, EU MDR, and other applicable international standards. Understand and maintain all pertinent standards, regulations, and requirements for Mobia’s business.
Ensure appropriate processes and systems for, and oversee, post-market surveillance activities, including Medical Device Reporting (MDR), Vigilance, Corrective and Preventive Actions (CAPA), field actions, and enterprise-wide quality and regulatory risk management.
Provide expertise and leadership to the design assurance function, to ensure appropriate design controls and traceability, risk management, verification and validation, a comprehensive design history file, and a compliant design transfer to production.
Develop and execute global regulatory strategies supporting IDE, 510(k), PMA, De Novo, and CE Mark submissions while serving as the organization's Person Responsible for Regulatory Compliance (PRRC-MDR).
Lead FDA inspections, global regulatory audits, and interactions with health authorities, including responses to inspections, audits, and technical documentation reviews.
Partner with Clinical, R&D, Operations, and Manufacturing teams to integrate quality, design assurance, and regulatory requirements throughout product development and sustaining engineering activities.
Collaborate with Legal to ensure ongoing compliance with applicable business and regulatory requirements.
Build, mentor, and lead a high-performing global Quality and Regulatory Affairs organization while establishing meaningful quality metrics and driving continuous improvement.
Serve as the executive authority on quality and regulatory compliance, providing strategic guidance to senior leadership and cross-functional stakeholders.