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Senior Regulatory Affairs Specialist — FDA Submissions & Compliance

Job in Boston, Suffolk County, Massachusetts, 02298, USA
Listing for: Miltenyi Biotec
Full Time position
Listed on 2026-01-27
Job specializations:
  • Healthcare
    Healthcare Compliance, Healthcare Management
Salary/Wage Range or Industry Benchmark: 125000 - 150000 USD Yearly USD 125000.00 150000.00 YEAR
Job Description & How to Apply Below
A biomedical research company in Boston is seeking a Regulatory Affairs Specialist to manage regulatory filings and submissions for product compliance. You will independently handle timelines, write submissions to the FDA and Canadian Health Authorities, and develop corporate strategies to expedite approvals. The ideal candidate possesses a Bachelor's degree in Biotechnology or Pharmaceutical Studies and has 5-8 years of relevant experience.

This role offers competitive salary and benefits in a collaborative environment.
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Position Requirements
10+ Years work experience
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