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Regulatory Affairs Specialist
Job in
New York, New York County, New York, 10261, USA
Listed on 2026-01-17
Listing for:
Barrington James Limited
Full Time
position Listed on 2026-01-17
Job specializations:
-
Healthcare
Healthcare Compliance, Medical Science Liaison
Job Description & How to Apply Below
Location: New York
Regulatory affairs specialist
Working with an exciting biotech company that has grown by over 75% in the last two years and is looking for a regulatory affair specialist to enhance their team. This company is focusing on pushing the limits of innovation and supply in global health!
Key responsibilities- Supporting the preparation, review and correct submission of regulatory documentation for medical device/IVDs products ensuring compliance with all regulatory requirements including FDA, ISO 13485.
- Help to prepare PMA packages, including nonclinical, manufacturing, and clinical sections.
- Working on analytical performance test with product development teams to draft documentation
- Bachelor’s degree in regulatory affairs, engineering and life sciences or a health or science related field is required.
- 2+ years of regulatory affairs experience within the medical device or IVD industry.
- Experience interacting with FDA regulations and guidance (510k).
If interested in this role feel free to contact by email at.
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