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Senior Regulatory Affairs Specialist - Medical Devices (Hybrid

Job in False Pass, Alaska, 99583, USA
Listing for: 6AM City, LLC
Full Time position
Listed on 2026-08-18
Job specializations:
  • Healthcare
    Medical Science Liaison
Salary/Wage Range or Industry Benchmark: 85000 - 110000 USD Yearly USD 85000.00 110000.00 YEAR
Job Description & How to Apply Below
Position: Senior Regulatory Affairs Specialist - Medical Devices (Hybrid)
Location: False Pass

6AM City, LLC is seeking a Sr. RA Specialist for a hybrid role based in Pennsylvania. The position supports FDA submissions (510(k)/NTF) for US, Canada, and EU, and maintains regulatory databases and labeling for medical devices.

Requires a Bachelor's degree and 4–6 years in Regulatory Affairs with experience supporting regulatory teams. Key duties include compiling submissions, interfacing with Product Development, updating change controls, and advising on regulatory strategy to ensure

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Position Requirements
10+ Years work experience
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