Regulatory Affairs Specialist: FDA Submissions & Strategy

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan with company match

Paid time off

Professional development

Job summary

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%.

Qualifications

• In-depth understanding of regulatory requirements throughout the medical product lifecycle.
• Strong understanding of drugs, biologics, blood/blood products, medical devices and/or related medical solutions.
• Strong analytical and problem-solving ability.
• Ability to work independently and collaboratively.
• Travel: Up to 20%.

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 devices

Regulatory submissions

Clinical/preclinical development

Job description

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%.