Arcetyp LLC is looking for a Senior DoD Regulatory Affairs Specialist - Medical Products. This position is onsite and located in Fort Detrick, MD.
ESSENTIAL JOB FUNCTIONS:
- Develop and review regulatory strategies for drugs, biologics, blood products, and medical devices.
- Prepare/review INDs, NDAs, PMAs, 510(k)s, technical files and clinical evaluation reports.
- Support FDA/regulatory agency interactions.
- Conduct regulatory gap analyses.
- Advise product managers and IPTs on regulatory risk and product lifecycle strategy.
NECESSARY SKILLS AND KNOWLEDGE:
- FDA regulatory affairs.
- Medical product development lifecycle.
- Drugs, biologics and/or medical devices.
- Regulatory submissions.
- Clinical/preclinical development.
MINIMUM QUALIFICATIONS:
- In-depth understanding of regulatory requirements throughout the medical product lifecycle.
- Strong understanding of drugs, biologics, blood/blood products, medical devices and/or related medical solutions.
- Strong analytical and problem-solving ability.
- Ability to work independently and collaboratively.
- Travel: Up to 20%
PREFERRED QUALIFICATIONS:
- Current WEMT Regulatory Affairs incumbent.
- Direct IND/NDA/PMA/510(k) experience.
- FDA meeting/submission experience.
- DoD/DHA medical product experience.
- RAC or comparable regulatory credential.
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.
