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.

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