Regulatory Affairs Specialist — FDA Submissions & Strategy

Goldbelt, Inc.; Maryland; Hybrid; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company matching

Tax-deferred savings options

Paid time off

Professional development opportunities

Job summary

Goldbelt Apex is seeking a Regulatory Affairs Support – WEMT to lead regulatory strategies for drugs, biologics, blood products, and medical devices. You will prepare and review INDs, NDAs, PMAs, 510(k)s, and clinical evaluations while supporting FDA interactions and regulatory analyses.

The role requires deep knowledge of regulatory submissions across the medical product lifecycle and collaboration with product teams to minimize risk and ensure compliance.

Qualifications

• FDA regulatory affairs throughout medical product lifecycle.
• Experience with drugs, biologics, blood products and/or medical devices.
• Regulatory submissions (INDs, NDAs, PMAs, 510(k)s).
• Clinical/preclinical development knowledge.

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 on regulatory risk and lifecycle strategy.

Skills

FDA regulatory affairs

Medical product lifecycle

Drugs biologics devices

Regulatory submissions

Clinical/preclinical development

Job description

Goldbelt Apex is seeking a Regulatory Affairs Support – WEMT to lead regulatory strategies for drugs, biologics, blood products, and medical devices. You will prepare and review INDs, NDAs, PMAs, 510(k)s, and clinical evaluations while supporting FDA interactions and regulatory analyses.

The role requires deep knowledge of regulatory submissions across the medical product lifecycle and collaboration with product teams to minimize risk and ensure compliance.