Senior DoD Regulatory Affairs Lead — Medical Products

Arcetyp LLC; Gaithersburg (MD); Remote; USD 110,000 - 150,000; Full time

Job summary

Arcetyp LLC is seeking a Senior DoD Regulatory Affairs Specialist - Medical Products for an onsite role in Fort Detrick, MD. You will develop and review regulatory strategies for drugs, biologics, blood products, and medical devices, and prepare or review INDs, NDAs, PMAs, 510(k)s, technical files, and clinical evaluation reports.

You will also support FDA and other regulatory agency interactions. Minimum qualifications emphasize an in-depth understanding of regulatory requirements across the

Qualifications

• FDA regulatory affairs.
• Medical product development lifecycle.
• Drugs, biologics and/or medical devices.
• Regulatory submissions.
• Clinical/preclinical development.

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.

Job description

Arcetyp LLC is seeking a Senior DoD Regulatory Affairs Specialist - Medical Products for an onsite role in Fort Detrick, MD. You will develop and review regulatory strategies for drugs, biologics, blood products, and medical devices, and prepare or review INDs, NDAs, PMAs, 510(k)s, technical files, and clinical evaluation reports.

You will also support FDA and other regulatory agency interactions. Minimum qualifications emphasize an in-depth understanding of regulatory requirements across the