Vice President, Regulatory Affairs & Quality Assurance

Location: Minneapolis, MN
Employment Type: Full‑Time | On‑site/Hybrid
Industry: Medical Devices (Class I-III)

About the Company

We are an emerging medical technology company headquartered in Minneapolis, focused on designing, developing, and manufacturing innovative Class I, II, and III medical devices that improve patient outcomes and elevate standards of care. As we expand our portfolio and global footprint, we are seeking a seasoned leader to guide our regulatory and quality functions through our next stage of growth.

Position Overview

The Vice President of Regulatory Affairs & Quality Assurance will serve as the executive leader responsible for developing and executing the company's global regulatory strategy while overseeing the quality management system (QMS). The role is heavily weighted toward Regulatory Affairs, including regulatory strategy, submissions, and interactions with regulatory bodies. This position reports directly to the CEO and is a key member of the executive leadership team.

Key Responsibilities

• Develop and lead global regulatory strategies for Class I-III medical devices for the United States, EU, Canada, and additional target markets.
• Oversee preparation, authoring, and submission of regulatory filings, including 510(k), PMA, IDE, technical files, design dossiers, and international registrations.
• Serve as the primary liaison with FDA, Notified Bodies, and other regulatory authorities, leading all regulatory communications, meetings, and inspections.
• Provide strategic regulatory input during product development, including design controls, risk management, labeling, claims, and post‑market considerations.
• Lead regulatory intelligence activities to stay ahead of regulatory changes, emerging standards, and new guidance documents.
• Support clinical and pre‑clinical strategy from a regulatory perspective, ensuring alignment with submission pathways and evidence requirements.
• Guide cross‑functional teams to ensure regulatory requirements are embedded throughout development, manufacturing, and commercialization.
• Oversee the company's Quality Management System (QMS) to maintain compliance with FDA QSR, ISO 13485, EU MDR, and other applicable regulations.
• Provide executive oversight of audits (internal and supplier), CAPA, complaint handling, nonconformance management, production quality controls, and risk management processes.
• Support manufacturing, engineering, and post‑market surveillance with quality leadership and direction.
• Foster a strong culture of quality and compliance across the organization.
• Mentor and develop regulatory and quality teams, ensuring strong leadership, technical depth, and succession planning.

Qualifications

Required

• Bachelor's degree in engineering, life sciences, or a related technical field.
• 12+ years of progressive regulatory affairs experience in the medical device industry.
• Proven success leading regulatory strategy and submissions for Class II and Class III medical devices.
• Deep working knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, EU MDR, and global regulatory frameworks.
• Demonstrated leadership experience managing RA/QA teams and cross‑functional initiatives.
• Strong track record of productive interactions with FDA and Notified Bodies.

Preferred

• Master's degree or advanced technical/scientific degree.
• Experience in a small or emerging medtech environment requiring hands‑on leadership.
• Experience with combination products, software‑enabled devices, or digital health technologies.

Key Attributes

• Strategic thinker who translates regulatory insights into business decisions.
• Strong communicator capable of representing the company confidently in regulatory discussions.
• Collaborative leadership style suitable for a fast‑paced, dynamic environment.
• High integrity, sound judgment, and strong commitment to patient safety and product excellence.

What We Offer

• Opportunity to shape regulatory and quality strategy for a high‑growth medtech innovator.
• Executive‑level influence and visibility.
• Competitive compensation, equity participation, and comprehensive benefits.
• A mission‑driven culture focused on innovation and improving patient outcomes.