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Regulatory & Quality Leader Medical Devices; SaMD

Job in Boston, Suffolk County, Massachusetts, 02298, USA
Listing for: Cedent Consulting
Full Time position
Listed on 2025-12-08
Job specializations:
  • Healthcare
    Medical Science
  • Quality Assurance - QA/QC
Job Description & How to Apply Below
Position: Regulatory & Quality Leader for Medical Devices (SaMD)
An established industry player is seeking a Clinical, Regulatory, and Quality Manager to oversee FDA submissions and develop standard operating procedures for a scalable Quality Management System. This role requires 3-5 years of experience in Clinical, Regulatory, and Quality roles, particularly within the medical devices or healthtech sectors. The ideal candidate will thrive in a dynamic startup environment and possess strong knowledge of FDA processes and ISO 13485.

Join a forward-thinking company where you can make a significant impact on product development and quality assurance.
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