Senior Manager of Quality and Regulatory

Title: Senior Manager of Quality and Regulatory

Location: Plymouth, MN

Job Type: Permanent

Compensation: $170,000 - $180,000 + Bonus

Industry: Medical Device and Healthcare Technology

We are partnering with a well-established medical device company based in Plymouth, MN to identify a Senior Manager of Quality & Regulatory. Our client is an innovative organization that designs and manufactures advanced medical devices used in clinical and patient care settings around the world. This is an exciting opportunity to join a mission-driven company where quality, compliance, and product innovation directly impact patient outcomes.

The Senior Manager of Quality & Regulatory will provide leadership for Quality Systems, Design Assurance, and Regulatory Affairs across the organization. Reporting to executive leadership, this individual will balance strategic thinking with operational execution—ensuring compliance with global medical device regulations while enabling business growth and product innovation.

The ideal candidate is a collaborative and influential leader who can effectively partner across departments, provide objective guidance, and confidently address compliance risks and quality concerns—even when delivering difficult messages. This individual will lead a high-performing team while driving continuous improvement and regulatory excellence throughout the organization.

• Lead and oversee the Quality Systems function to ensure compliance with FDA, ISO 13485, MDSAP, and other applicable regulatory requirements.
• Drive continuous improvement initiatives related to quality processes, procedures, and systems.
• Ensure inspection readiness and lead activities related to internal audits, external audits, and regulatory inspections.
• Partner with cross-functional teams to identify, assess, and mitigate quality risks.
• Monitor quality performance metrics and implement corrective and preventive actions as needed.

• Lead Design Assurance activities throughout the product lifecycle, ensuring compliance with design control requirements and regulatory expectations.
• Partner closely with Engineering, R&D, Manufacturing, and Product Management teams to support new product development and sustaining engineering efforts.
• Provide quality oversight for risk management, verification, validation, and product change processes.
• Support organizational growth by building and expanding the Design Assurance function.

• Oversee global regulatory strategies and submissions for medical device products.
• Ensure compliance with FDA regulations, international regulations, and applicable standards.
• Provide regulatory guidance for product development, labeling, claims, and market expansion initiatives.
• Maintain awareness of evolving regulatory requirements and assess impact on the organization.

• Lead a team of six direct reports across Design Assurance, Quality Systems, and Regulatory Affairs.
• Develop and mentor team members while fostering a culture of accountability, collaboration, and continuous improvement.
• Establish priorities, allocate resources, and drive execution against departmental objectives.
• Serve as a trusted advisor and business partner to executive leadership and cross-functional stakeholders.

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related field.
• 10+ years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
• Demonstrated leadership experience managing quality and regulatory teams.
• Strong knowledge of FDA Quality System Regulations (21 CFR Part 820), Design Controls and Design Assurance, ISO 13485, Risk Management (ISO 14971), and global medical device regulatory requirements.
• Experience supporting regulatory submissions, audits, and inspections.
• Proven ability to influence cross-functional teams and drive organizational change.

• Advanced degree and/or professional certifications (ASQ, RAC, etc.).
• Experience with Class II and/or Class III medical devices.
• Experience…