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

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.

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.

Arcetyp is an Equal Opportunity Employer and we highly value diversity of our workforce. We accept resumes from all interested parties and consider applicants for all positions without regard to race, color, religion, sex, national origin, age, marital status, sexual preference, personal appearance, family responsibility, the presence of a non-job-related medical condition or physical disability, matriculation, political affiliation, veteran status, or any other legally protected status.