Senior DoD Regulatory Affairs Specialist – Medical Products - Telework

Arcetyp LLC•Gaithersburg, MD

8d•Onsite

About The Position

Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management & IT Consulting, Program & Project Management, and Professional & Admin Services. This position is for a Senior DoD Regulatory Affairs Specialist focusing on Medical Products. The role requires an in-depth understanding of regulatory requirements throughout the medical product lifecycle and experience with drugs, biologics, blood products, and medical devices. The position is located at Fort Detrick, MD, and requires up to 20% travel.

Requirements

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

Nice To Haves

Current WEMT Regulatory Affairs incumbent.
Direct IND/NDA/PMA/510(k) experience.
FDA meeting/submission experience.
DoD/DHA medical product experience.
RAC or comparable regulatory credential.

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.