Job Description

Director of Regulatory Affairs – Medical Devices | On-Site | Portland, OR

A leading medical device company is seeking an experienced Director of Regulatory Affairs to join their team at their corporate headquarters in Portland, Oregon . This is a great opportunity to play a key role in regulatory strategy, compliance, and leadership within a company that specializes in innovative surgical and medical technologies .

About the Role

As the Director of Regulatory Affairs , you will be responsible for ensuring compliance with global regulatory requirements (FDA, EU MDR, ISO 13485, etc.) , overseeing internal audits, and guiding regulatory strategies. You'll work cross-functionally with internal teams and regulatory authorities to navigate product approvals and maintain high compliance standards.

Key Responsibilities

• Develop and implement regulatory strategies for new and existing medical devices.
• Monitor evolving global regulations and advise teams on compliance impact.
• Oversee regulatory submissions, including FDA (510(k), PMA), CE marking, EU MDR compliance , etc.
• Lead and mentor the Regulatory Affairs (RA) team , ensuring strong execution of regulatory processes.
• Maintain all necessary technical documentation and regulatory records .
• Conduct internal audits and compliance reviews to uphold quality standards.
• Provide training and coaching on regulatory best practices across departments.

Qualifications

• Bachelor's degree in science, engineering, or healthcare-related field .
• 7+ years of regulatory experience in a medical device setting.
• Strong knowledge of FDA, ISO 13485, QSR, cGMP, and EU MDR requirements .
• Proven experience with regulatory submissions and product approvals .
• Excellent leadership, project management, and communication skills.

What’s in it for you?

• Competitive compensation and comprehensive benefits package.
• Medical, dental, vision, 401(k) with company match , and more.
• A collaborative environment focused on cutting-edge medical technology .

On-site position in Portland, OR.

If you are interested in this opportunity, apply now.

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