Senior DoD Regulatory Affairs Specialist – Medical Products - Telework

Arcetyp LLC•Gaithersburg, MD

1d•Onsite

About The Position

Arcetyp LLC is seeking a Senior DoD Regulatory Affairs Specialist to support medical products. The position is onsite in Fort Detrick, Maryland. The specialist develops and reviews regulatory strategies for drugs, biologics, blood products, and medical devices; prepares and reviews regulatory submissions; supports interactions with the FDA and other regulatory agencies; conducts regulatory gap analyses; and advises product managers and integrated product teams on regulatory risk and product lifecycle strategy. Travel may be required up to 20%. U.S. citizenship is required. The role is a direct-hire W-2 position; the company does not accept 1099 independent consultants, staffing firms, or corp-to-corp candidates and cannot sponsor H-1B visas.

Requirements

In-depth understanding of regulatory requirements throughout the medical product lifecycle.
Strong understanding of drugs, biologics, blood and 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, or 510(k) experience.
FDA meeting or submission experience.
DoD or DHA medical product experience.
RAC or comparable regulatory credential.

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 interactions with the FDA and other regulatory agencies.
Conduct regulatory gap analyses.
Advise product managers and integrated product teams on regulatory risk and product lifecycle strategy.