Regulatory Affairs Specialist: Drugs, Devices & Travel

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company matching

Paid time off

Professional development opportunities

Job summary

Goldbelt Apex LLC is seeking a Regulatory Affairs Support - WEMT to develop and review regulatory strategies for drugs, biologics, blood products, and medical devices. The role includes preparing regulatory submissions and supporting interactions with regulatory agencies.

The position requires deep knowledge of the medical product lifecycle, strong analytical skills, and the ability to work independently and collaboratively. Travel up to 20% may be required.

Qualifications

• FDA regulatory affairs knowledge across drugs, biologics, and medical devices.
• Experience with regulatory submissions (INDs, NDAs, PMAs, 510(k)s).
• Strong analytical and problem-solving abilities.

Responsibilities

• Develop and review regulatory strategies for drugs, biologics, blood products, and medical devices.
• Prepare and 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 lifecycle strategy.

Skills

FDA regulatory affairs

Medical product lifecycle

Drugs/biologics/devices

Regulatory submissions

Clinical/preclinical development

Analytical skills

Job description

Goldbelt Apex LLC is seeking a Regulatory Affairs Support - WEMT to develop and review regulatory strategies for drugs, biologics, blood products, and medical devices. The role includes preparing regulatory submissions and supporting interactions with regulatory agencies.

The position requires deep knowledge of the medical product lifecycle, strong analytical skills, and the ability to work independently and collaboratively. Travel up to 20% may be required.