Regulatory Affairs Director, Medical Devices

The Regulatory Affairs Director, Medical Devices with partner with executive leadership, Medical and Quality teams, consultants, regulatory agencies, and international stakeholders to support product approvals and ongoing compliance. Success in the Regulatory Affairs Director, Medical Devices role will include timely submissions, effective quality oversight, strong complaint and adverse event processes, and consistent adherence to applicable regulations.

Client Overview:
Our client is an established pharmaceutical organization that combines research and development, manufacturing, marketing, and sales capabilities across a broad healthcare product portfolio. The company supports products in several therapeutic areas and works with internal teams, external partners, and global regulatory stakeholders. They are currently looking to add a Regulatory Affairs Director, Medical Devices to their team.

Salary/Hourly Rate:
$175k Annually

Position Overview:
The Regulatory Affairs Director, Medical Devices will lead regulatory strategy, quality systems, and compliance activities for medical device and healthcare products in the United States and Canada. The Regulatory Affairs Director, Medical Devices with partner with executive leadership, Medical and Quality teams, consultants, regulatory agencies, and international stakeholders to support product approvals and ongoing compliance. Success in the Regulatory Affairs Director, Medical Devices role will include timely submissions, effective quality oversight, strong complaint and adverse event processes, and consistent adherence to applicable regulations.

Responsibilities of the Regulatory Affairs Director, Medical Devices:

• The Regulatory Affairs Director, Medical Devices will direct regulatory submissions and product registration activities for the United States and Canada.
• Lead submissions including PMAs and supplements, 510(k)s, 513(g)s, pre-submissions, annual reports, and letters to file.
• Maintain FDA, Canadian, medical device, and state-level registrations, listings, renewals, and compliance reports.
• Serve as the quality system representative for compliance with 21 CFR Part 820 and ISO 13485 requirements.
• Coordinate management reviews, internal and external audits, root-cause investigations, and corrective and preventive actions.
• Oversee complaint handling, adverse event reporting, medical inquiries, Medical Device Reporting, and recall-related activities.
• Manage regulatory personnel and provide oversight to quality assurance and pharmacovigilance quality activities.
• Develop regulatory strategies for new and innovative products to support market approval.
• Create and maintain policies, procedures, work instructions, technical reports, and vendor quality agreements.
• Review product labeling, promotional materials, and training content for regulatory compliance.
• Support corporate compliance programs related to fraud and abuse laws and industry standards.
• Provide regulatory and compliance training to new employees.
• Collaborate with executive leadership, consultants, regulatory agencies, and international teams.
• Assist with state licenses and permits required for product sales.
• Travel as needed and perform additional duties related to regulatory and quality operations.

Required Experience/Skills for the Regulatory Affairs Director, Medical Devices:

• At least 10 years of experience in regulatory affairs, compliance, and quality systems.
• Working knowledge of FDA requirements for Class II and Class III medical devices.
• Working knowledge of Canadian medical device regulations.
• Experience with 21 CFR Parts 820, 803, and 806, as well as ISO 13485.
• Strong technical writing skills and experience preparing policies, procedures, work instructions, reports, and other regulated documentation.
• Ability to work independently, manage multiple priorities, and complete assignments effectively.
• Willingness and ability to travel as required.

Preferred Experience/Skills for the Regulatory Affairs Director, Medical Devices:

• RAC Certification.

Education Requiremetns:

• Bachelor's degree in a Science or Health-related discipline with applicable professional experience.

Benefits:

• Client-provided benefits available, upon eligibility.

Job Wrapping ID: #LI-AJ3

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EOE/M/F/D/V/SO

Position ID: 412140