Senior DoD Regulatory Affairs Specialist - Medical Products

Arcetyp LLC; Frederick (MD); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Medical, dental & vision insurance

401(k) with company matching

Job summary

Arcetyp LLC is seeking a Senior DoD Regulatory Affairs Specialist - Medical Products for an onsite role in Fort Detrick, MD. The position focuses on regulatory strategy development for drugs, biologics, blood products, and medical devices, with responsibility for IND/NDAs/PMAs/510(k) submissions and agency interactions.

The role requires DoD regulatory experience, strong analytical skills, and the ability to travel up to 20%.

Qualifications

• FDA regulatory affairs field knowledge and practical application.
• Understanding of the medical product regulatory lifecycle for drugs, biologics and devices.
• Experience with regulatory submissions across IND/NDAs/PMAs/510(k)s.
• Knowledge of regulatory risk assessment and lifecycle planning.
• Familiarity with clinical/preclinical development considerations.

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 and other regulatory agency interactions.
• Conduct regulatory gap analyses and advise on risk and lifecycle strategy.
• Collaborate with product managers and IPTs on regulatory planning.

Skills

FDA regulatory affairs

Regulatory lifecycle

Regulatory submissions

Medical products knowledge

Analytical/problem solving

Job description

Arcetyp LLC is seeking a Senior DoD Regulatory Affairs Specialist - Medical Products for an onsite role in Fort Detrick, MD. The position focuses on regulatory strategy development for drugs, biologics, blood products, and medical devices, with responsibility for IND/NDAs/PMAs/510(k) submissions and agency interactions.

The role requires DoD regulatory experience, strong analytical skills, and the ability to travel up to 20%.