Senior DoD Regulatory Affairs Specialist – Medical Products - Telework

Arcetyp LLC•Gaithersburg, MD

6d•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. We accept direct hire candidates only, W2 employee hires. We do not accept 1099 independent consultants. We do not accept staffing firms. We do not accept corp-to-corp (C2C) candidates. We can't sponsor H1B. Arcetyp LLC is looking for a Senior DoD Regulatory Affairs Specialist - Medical Products. This position is onsite and located in Fort Detrick, MD.

Requirements

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.