Job Description
Director of Regulatory Affairs – Medical Device Industry
ocation: Northern Seattle area (Primarily On-Site)
Employment Type: Full-Time
A growing, profitable medical device company with a global presence is seeking a Director of Regulatory Affairs to join their QA/RA leadership team. This is a high-impact role leading regulatory strategy across a diverse and innovative product portfolio, with more breakthrough devices in the pipeline.
Key Responsibilities:
- Serve as a strategic regulatory leader across the full product lifecycle, from development through post-market.
- Ensure global regulatory compliance for all products, aligning with FDA, EU MDR, and other international requirements.
- Oversee preparation and submission of regulatory filings, including FDA 510(k), EU Technical Files, and international registrations.
- Manage the planning and execution of clinical evaluations and regulatory aspects of clinical studies.
- Review and approve changes to product design, manufacturing, quality, and promotional materials for compliance.
- Lead, mentor, and develop a high-performing regulatory team, as well as external consultants and clinical partners.
- Act as a senior advisor to the executive leadership team on regulatory risk and strategy.
What We're Looking For:
- Bachelor's degree in a scientific or technical field (Master’s preferred).
- Minimum of 8 years’ experience in Regulatory Affairs within medical devices, pharma, biotech, or healthcare.
- At least 5 years’ experience in a leadership or people management role.
- Proven expertise with FDA, EU MDR, and global registration pathways, including 510(k) submissions and clinical evaluations.
- Strong leadership and interpersonal skills with the ability to influence across teams and functions.
- Excellent written and verbal communication skills.
This is a great opportunity for someone who thrives in a collaborative environment and is passionate about bringing life-changing technologies to market.
Job Tags
Full time,