Regulatory Affairs Director - Permanent - Seattle, WA Area
Proclinical is seeking a Director, Regulatory Affairs for a global medical device company. This is a permanent role based in the Seattle, WA Area.
Primary Responsibilities :
In this role, you will provide regulatory strategy and guidance to the R&D, Supply Chain, Quality and Commercial teams including collecting, monitoring, analyzing, and interpreting relevant regulations, guidance, and national / international standards.
Skills & Requirements :
- Bachelor's degree in a life science or technical discipline.
- 6-10 years of regulatory experience in medical device company (aesthetic devices is a plus).
- 3-6 years of people management, direct & indirect.
- Demonstrates thorough knowledge and expertise in Active Medical Device international regulations, focus on US / Canada / MDR and APAC is a plus.
- Experience on 510(K), Health Canada, EU MDD / MDR Technical Documentations, STEDs for global registration purposes as appropriate, related submission work.
- Experience with complex regulatory activities, effectively and efficiently facilitates discussions with regulatory authorities.
The Director, Regulatory Affairs will :
- Develop, consult, review, and approve the Regulatory Affairs Assessment during New Product Development and Maintenance of Business changes.
- Provide hands on support, leadership, and guidance to GRA team to complete 510(K), Health Canada, EU MDD / MDR Technical Documentations, Summary of Technical Documentation (STED) for global registration purpose as appropriate, and related submission work.
- Partner with other regions to support product global regulatory expansion.
- Work in collaboration with Group Promotional Review Committee Regulatory lead, ensuring regulatory compliance for company promotional materials and other promotional activities.
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or [email protected] .
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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