REGULATORY AFFAIRS SPECIALIST
50213
Posted: 13/01/2026
- New York, United States
- Permanent
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-
Benefits-
If interested in this role feel free to contact by email at.
hjohn@barringtonjames.com
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 5 years of regulatory affairs experience within the medical device or IVD industry.
- Experience interacting with FDA regulations and guidance (510k).
Benefits-
- Flexible paid time off policy
- Medical insurance 401 (k)
- Free parking
If interested in this role feel free to contact by email at.
hjohn@barringtonjames.com
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