What are the responsibilities and job description for the Director of Regulatory Affairs position at Arevna?
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
What’s in it for you?
On-site position in Portland, OR.
If you are interested in this opportunity, apply now.