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

Arcetyp LLC•Bethesda, 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 SME – Drugs, Biologics & Medical Devices. This position is onsite and located in Fort Detrick, MD.

Requirements

Senior FDA regulatory affairs expertise.
Drugs, biologics, blood/blood products and/or medical devices.
Product development lifecycle.
Regulatory submissions and agency interactions.
Clinical and preclinical development.
Cross-functional work 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.