Regulatory Affairs Director

6 days ago

Seattle, Washington, United States Proclinical Staffing Full time
Regulatory Affairs Manager

Proclinical is seeking a seasoned Regulatory Affairs Manager to join a global medical device company in Seattle, WA.

This permanent role will provide direct support to company operations for their globally distributed products, working closely with site Quality, R&D, Operations, and regional RA peers to ensure global licensing and registrations, and effective execution and management of changes.

Key Responsibilities:
  • Develop and implement global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy for product portfolio.
  • Lead regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
  • Provide the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, as well as leadership and guidance on global regulatory strategy, such as US FDA product clearance, Health Canada registration, CE Marking, global product registrations, and clinical evaluations.
Requirements:
  • Bachelor's degree in a scientific discipline is required. Advanced degree is preferred.
  • 10+ years of experience in medical device industry. 5+ years of experience in Electrical/Active medical device industry.
  • 5+ working knowledge of appropriate global medical device regulations, requirements, and standards.
  • 2+ years of people management experience, direct & indirect.
  • Should have experience of independently authoring complete 510k submissions, Health Canada Medical Device license applications (Class II or above), EU MDR technical file dossier (Class II or above).
  • Experience in participating in national or international standards activities.
  • Must be eligible to work in the US.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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