Regulatory Affairs Specialist: FDA Submissions & Strategy
Listed on 2026-10-06
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Healthcare
Healthcare Compliance
Goldbelt Apex seeks a Regulatory Affairs Support - WEMT to guide regulatory strategies across drugs, biologics, blood products and medical devices, ensuring compliance throughout the product lifecycle.
You will prepare and review INDs, NDAs, PMAs, 510(k) s, technical files and clinical evaluation reports, and support FDA interactions and regulatory gap analyses.
Collaborate with product managers and IPTs to assess regulatory risk and shape lifecycle strategy while traveling up to 20%.
The following opportunity is for a Regulatory Affairs Specialist: FDA Submissions & Strategy with Goldbelt Apex, LLC.
We invite applications for the Regulatory Affairs Specialist: FDA Submissions & Strategy position located in Frederick, MD, United States.
The following opening is for a Regulatory Affairs Specialist: FDA Submissions & Strategy with Goldbelt Apex, LLC.
Our group is growing, and we are hiring a Regulatory Affairs Specialist: FDA Submissions & Strategy in Frederick, MD, United States.
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