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Verathon, Inc.
Bothell, WA, United States
Verathon, Inc. Senior Regulatory Affairs Specialist Bothell , Washington Apply Now Senior Regulatory Affairs Specialist - VerathonVerathon is seeking a highly experienced and motivated Senior Regulatory Affairs Specialist to join our dynamic QA/RA Team in Bothell, WA. As a key member of our team, you will play a crucial role in mana
Job Source: Verathon, Inc.Philips
Bothell, WA, United States
Job Title Senior Regulatory Affairs Specialist Job Description Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all. In this role you have the opportunity to Respon
Job Source: PhilipsTerraPower
Bellevue, WA, United States
TITLE: Deputy and Senior Director, Regulatory Affairs LOCATION: Bellevue, WA, USA TerraPower is a nuclear technology company based in Bellevue, Washington. At its core, the company is working to raise living standards globally through a more affordable, secure, and environmentally friendly form of nuclear energy along with innovation
Job Source: TerraPowerTerraPower
Bellevue, WA, United States
TITLE: Deputy and Senior Director, Regulatory Affairs LOCATION: Bellevue, WA, USA TerraPower is a nuclear technology company based in Bellevue, Washington. At its core, the company is working to raise living standards globally through a more affordable, secure, and environmentally friendly form of nuclear energy along with innovations in medical
Job Source: TerraPowerFred Hutchinson Cancer Research Center
Seattle, WA, United States
Fred Hutch is proud to be an Equal Opportunity and VEVRAA Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, sexual orientation,
Job Source: Fred Hutchinson Cancer Research CenterCareOregon
Seattle, WA, United States
Career Opportunities: Director, Regulatory Affairs (24369) Requisition ID 24369 - Posted 06/27/2024 - CareOregon - Full Time - Permanent - Portland - Multi Location (2) Job Description Print Preview Job Title Director, Regulatory Affairs Department Legal Affairs Exemption Status Exempt Requisition # 24369 Direct Reports Regula
Job Source: CareOregonCareOregon Inc.
Seattle, WA, United States
CareOregon Inc. Director, Regulatory Affairs Seattle , Washington Apply Now Career Opportunities: Director, Regulatory Affairs (24369)Requisition ID 24369 - Posted 06/27/2024 - CareOregon - Full Time - Permanent - Portland - Multi Location (2)Job Description Print PreviewJob TitleDirector, Regulatory AffairsDepartmentLegal AffairsExem
Job Source: CareOregon Inc.CareOregon
Seattle, WA, United States
Career Opportunities: Director, Regulatory Affairs (24369) Requisition ID 24369 - Posted 06/27/2024 - CareOregon - Full Time - Permanent - Portland - Multi Location (2) Job Description Print Preview Job Title Director, Regulatory Affairs Department Legal Affairs Exemption Status Exempt Requisition # 24369 Direct Reports Regu
Job Source: CareOregonSeattle, WA, United States
(Senior) Manager, Regulatory Affairs - Permanent - Seattle, WA
Proclinical is seeking a (Senior) Manager, Regulatory Affairs for a global medical device company. This is a permanent role based at the company's manufacturing site in the Greater Seattle, WA Area.
Primary Responsibilities:
In this role, you will provide direct support to company operations for their globally distributed products. This role is a global regulatory position, working closely with site Quality, R&D, Operations, and regional RA peers to support global licensing and registrations, and to ensure the effective execution and management of changes.
Skills & 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: 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.
The (Senior) Manager, Regulatory Affairs will:
Responsible for developing and implementing global regulatory strategy and roadmaps through deep understanding of the competitive market landscape, regulatory / legislative initiatives, and product marketing strategy for product portfolio.
Leads regulatory resources to ensure timely product registrations, regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
Provides 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.
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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Email Alert for Senior Regulatory Affairs Manager jobs in Seattle, WA, United States
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