Regulatory Affairs Specialist - Drug & Device; FDA)
Listed on 2026-10-06
-
Healthcare
Healthcare Compliance, Medical Science Liaison
Goldbelt Apex is seeking a Regulatory Affairs Support to develop and review regulatory strategies for drugs, biologics, blood products, and medical devices. The role involves preparing INDs/NDAs/PMAs/510(k) s, technical files, and clinical evaluation reports while supporting FDA interactions.
The candidate will conduct regulatory gap analyses and advise product managers on regulatory risk and lifecycle strategy, contributing to program success across the medical product portfolio.
We are seeking a motivated Regulatory Affairs Specialist
- Drug & Device (FDA) to join Goldbelt, Inc. in Frederick, MD, United States.
As a Regulatory Affairs Specialist
- Drug & Device (FDA), you will play an important part at Goldbelt, Inc. in Frederick, MD, United States.
We invite applications for the Regulatory Affairs Specialist
- Drug & Device (FDA) position located in Frederick, MD, United States.
(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).