Director of Regulatory Affairs at Confidential Company ...

Director of Regulatory Affairs job at Confidential Company. Seattle, WA.Director of Regulatory Affairs – Medical Device Industryocation: Northern Seattle area (Primarily On-Site)Employment Type: Full-TimeA 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. #J-18808-Ljbffr

Created: 2025-10-06