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Senior Principal Regulatory Affairs Specialist
Job in
Bedford, Bedfordshire, MK40, England, UK
Listed on 2026-02-20
Listing for:
Werfen
Full Time
position Listed on 2026-02-20
Job specializations:
-
Healthcare
Healthcare Compliance
Job Description & How to Apply Below
Overview
Position Summary:
Responsible to manage pre-market regulatory activities required to maintain compliance to US FDA, Health Canada and EU IVD Regulations (EU) /46, as well as other country regulatory agencies. Represents regulatory on design teams, prepares regulatory plans, authors US FDA (k) s, Health Canada license and EU Notified Body submissions and interfaces with these agencies through submission completion. Acts as reviewer on product labeling, including commercial materials such as brochures and presentations, for regulatory compliance.
Position Requirements
10+ Years
work experience
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