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.
ESSENTIAL JOB FUNCTIONS:
- 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.
NECESSARY SKILLS AND KNOWLEDGE:
- 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.
MINIMUM QUALIFICATIONS:
- 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.
PREFERRED QUALIFICATIONS:
- 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.
Min. Citizenship Status Required:
U.S Citizenship.
LOCATION:
Fort Detrick, MD
COMPENSATION: Pay and benefits information for this position will be provided to interested candidates that apply. Arcetyp offers a package of compensation and benefits to full-time salaried employees. Pay and Benefits from our client: we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.
