Senior DoD Regulatory Affairs SME – Drugs, Biologics & Medical Devices

Arcetyp LLC•Fort Detrick, MD

8d•Onsite

About The Position

Arcetyp LLC is seeking a Senior DoD Regulatory Affairs SME with expertise in Drugs, Biologics, and Medical Devices. This role supports military-relevant medical solutions by providing senior regulatory subject matter expertise. The position is a direct hire, W2 employee role, located onsite in Fort Detrick, MD. Arcetyp LLC is a growing small business offering a broad range of consulting services to US Federal Government, US Military, and Commercial clients.

Requirements

Senior FDA regulatory affairs expertise.
Expertise in Drugs, biologics, blood/blood products and/or medical devices.
Knowledge of Product development lifecycle.
Experience with Regulatory submissions and agency interactions.
Understanding of Clinical and preclinical development.
Experience working cross-functionally with R&D, manufacturing, clinical and product management.
U.S Citizenship.

Nice To Haves

Current WPAC Regulatory Affairs incumbent(s) highest-priority incumbent capture target.
Direct experience preparing IND/NDA/PMA/510(k) submissions.
FDA meeting and regulatory agency interaction experience.
Blood/biologics/combat casualty care regulatory experience.
DHA/DoD medical acquisition experience.
RAC or comparable regulatory certification.

Responsibilities

Serve as senior regulatory SME supporting military-relevant drugs, biologics, blood products, medical devices and other medical solutions.
Develop and review regulatory strategies and submission plans.
Prepare/review INDs, NDAs, PMAs, 510(k)s, Technical Files, Clinical Evaluation Reports, meeting packages, audit reports and inspection products.
Support interactions with FDA/regulatory agencies and sponsors.
Advise product managers/IPTs on regulatory risks, opportunities and lifecycle strategy.
Mentor teams on regulatory requirements and best practices.