Director of Regulatory Affairs Job at Arevna, Portland, OR

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  • Arevna
  • Portland, OR

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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