Director of Regulatory & Quality (Medical Devices)

About the Role:

We are seeking an accomplished Director of Regulatory & Quality to lead all regulatory affairs and quality assurance functions for a medical device organization. This role ensures full compliance with FDA, ISO 13485, MDSAP, and EU MDR standards while driving continuous improvement across all quality systems. The ideal candidate will provide strategic leadership in regulatory submissions, quality management system (QMS) development, and compliance oversight to support product safety, efficacy, and global market access. This is a high-impact position requiring extensive regulatory expertise, leadership ability, and a strong background in medical device quality systems and international compliance frameworks.

Responsibilities:

• Lead all regulatory and quality assurance activities for medical devices, ensuring compliance with FDA QSR (21 CFR 820), ISO 13485, MDSAP, and EU MDR requirements.

• Develop, implement, and maintain an integrated Quality Management System (QMS) aligned with U.S. and international regulatory expectations.

• Oversee the preparation, submission, and maintenance of FDA 510(k), Technical Files, Design Dossiers, and global product registrations.

• Manage internal, external, and supplier audits, including MDSAP audits and notified body assessments, ensuring ongoing compliance and certification readiness.

• Collaborate with R&D, manufacturing, and supply chain to ensure design control, validation, risk management, and document control align with ISO and FDA standards.

• Direct post-market surveillance, complaint handling, CAPA, nonconformance management, and change control processes to maintain product quality and regulatory compliance.

• Serve as the primary liaison with FDA, notified bodies, and regulatory agencies, managing inspections, submissions, and corrective action responses.

• Lead management reviews, quality system training, and compliance initiatives to drive continuous improvement.

• Ensure compliance with environmental, health, and safety regulations relevant to medical device manufacturing and operations.

• Mentor and develop regulatory and quality teams to support departmental and organizational objectives.

Qualifications:

• Bachelors degree in Engineering, Life Sciences, or a related technical field.

• Minimum 10 years of progressive experience in regulatory affairs and quality assurance within the medical device industry.

• Proven expertise in FDA QSR, ISO 13485, EU MDR, and MDSAP compliance management.

• Demonstrated success in preparing and maintaining FDA 510(k) submissions and international regulatory documentation.

• Strong experience with supplier quality management, auditing, and CAPA systems.

• In-depth knowledge of risk management (ISO 14971), validation, and design control requirements.

• Experience leading audits and interacting directly with FDA inspectors and notified bodies.

• Strong analytical, organizational, and leadership skills with the ability to manage multiple priorities.

Desired Qualifications:

• Masters degree in Regulatory Affairs, Quality Management, or Biomedical Engineering.

• ASQ Certified Quality Manager (CQM), Certified Quality Engineer (CQE), or equivalent professional certification.

• Experience with PPAP, process validation, and supplier qualification in medical device environments.

• Familiarity with OSHA, EPA, and environmental compliance within regulated manufacturing.

• Proven success developing and executing regulatory strategies to support new product introductions and global market expansion.