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.
