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Senior Regulatory Affairs Leader – Remote, Global Device Strategy
Remote / Online - Candidates ideally in
Boston, Suffolk County, Massachusetts, 02298, USA
Listed on 2026-08-11
Boston, Suffolk County, Massachusetts, 02298, USA
Listing for:
Getinge
Remote/Work from Home
position Listed on 2026-08-11
Job specializations:
-
Management
Regulatory Compliance Specialist -
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Getinge seeks a Senior Manager, Regulatory Affairs to lead regulatory strategy for U.S., EU, and ROW, enabling safe, compliant market access for SWICC products and related devices. This role partners with product development, quality, operations, and global teams to embed regulatory risk management early in the lifecycle.
The position requires deep knowledge of FDA 510(k), EU MDR, QMS, and product labeling, plus a track record of successful submissions and audits.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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