Director of Regulatory & Quality (Medical Devices)

About the Role :

The Director of Regulatory & Quality will lead all regulatory affairs and quality assurance functions for a medical device organization, ensuring full compliance with FDA, ISO, and international regulatory standards. This senior-level position is responsible for developing and implementing quality management systems, regulatory submissions, and compliance strategies to support product safety, performance, and market access. The role requires strong leadership, deep expertise in medical device regulations, and the ability to guide cross-functional teams in maintaining exceptional quality and compliance standards across all operations.

Responsibilities :

• Oversee all regulatory and quality assurance activities related to medical devices, ensuring adherence to FDA QSR (21 CFR 820), ISO 13485, and EU MDR requirements.
• Develop, implement, and maintain quality management systems and regulatory policies aligned with U.S. and international medical device standards.
• Lead preparation, submission, and maintenance of FDA 510(k), Technical Files, and international product registrations.
• Manage internal and external audits, supplier quality audits, and management reviews to maintain compliance and continuous improvement.
• Collaborate with engineering, manufacturing, and supply chain teams to ensure design control, risk management, and validation processes meet regulatory expectations.
• Oversee post-market surveillance, complaint investigations, CAPA, nonconformance, and change control processes.
• Serve as the main contact with regulatory agencies, notified bodies, and certification authorities during audits and inspections.
• Ensure compliance with OSHA, EPA, and other safety and environmental regulations as they relate to product quality and facility operations.
• Lead and mentor the regulatory affairs and quality assurance team to achieve departmental and organizational goals.

Qualifications :

Desired Qualifications :