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

Arcetyp LLC•Gaithersburg, 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 US Federal Government and US Military clients, focusing on military-relevant medical solutions. The position is a direct hire, W2 employee role, and does not accept 1099, staffing firms, or C2C candidates. Sponsorship for H1B is not available. The role requires extensive experience with FDA regulatory affairs and product development lifecycles within the DoD context.

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.
Experience with 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.