Regulatory Affairs Specialist - Drug & Device (FDA)

Goldbelt, Inc.; Frederick (MD); On-site; USD 95,000 - 125,000; Full time

Job summary

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.

Qualifications

• Understanding of regulatory requirements across the medical product lifecycle.
• Knowledge of drugs, biologics, blood/blood products, medical devices.
• Ability to analyze regulatory pathways and propose compliant strategies.

Responsibilities

• Develop and review regulatory strategies for drugs, biologics, blood products, and medical devices.
• Prepare/review INDs, NDAs, PMAs, 510(k)s, technical files and clinical evaluation reports.
• Support FDA/regulatory agency interactions.
• Conduct regulatory gap analyses.
• Advise product managers and IPTs on regulatory risk and product lifecycle strategy.

Skills

FDA regulatory affairs

Medical product lifecycle

Drugs/biologics/medical devices

Regulatory submissions

Clinical/preclinical development

Job description

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.