Senior DoD Regulatory Affairs Specialist – Medical Products - Telework

Arcetyp LLC; Gaithersburg (MD); Remote; USD 110,000 - 150,000; Full time

Job summary

Arcetyp LLC is seeking a Senior DoD Regulatory Affairs Specialist - Medical Products for an onsite role in Fort Detrick, MD. You will develop and review regulatory strategies for drugs, biologics, blood products, and medical devices, and prepare or review INDs, NDAs, PMAs, 510(k)s, technical files, and clinical evaluation reports.

You will also support FDA and other regulatory agency interactions. Minimum qualifications emphasize an in-depth understanding of regulatory requirements across the

Qualifications

• FDA regulatory affairs.
• Medical product development lifecycle.
• Drugs, biologics and/or medical devices.
• Regulatory submissions.
• Clinical/preclinical development.

Responsibilities

• 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.

Job description

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 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. 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.