Combination Product (Medical Device) Reviewer

Tunnell Government Services • Bethesda, MD

10h • Remote

About The Position

Tunnell Government Services, Inc. is seeking a candidate to provide expert consulting services to assist the FDA Center for Devices and Radiological Health (CDRH) with their regulatory responsibilities. This role specifically involves the evaluation of pre-market submissions and lifecycle applications for medical products that combine medical devices with drugs and/or devices (e.g., drug-eluting stents, pre-filled syringes, inhalers). The mission of CDRH is to protect and promote public health by ensuring timely access to safe, effective, and high-quality medical devices and radiation-emitting products. The Office of Clinical Evidence and Analysis within CDRH's Office of Product Evaluation and Quality (OPEQ) provides policy and program support related to clinical trials, biostatistics, real-world evidence, and epidemiological analysis. Consultants in this role will support medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions), participate in meetings, coordinate stakeholder interactions, develop written reviews and correspondence, write detailed documents and reports, and execute other administrative tasks.

Requirements

• Bachelor’s degree (BS) in a relevant field.
• 5-7 years of applicable experience is required.
• Demonstrate advanced professional experience in scientific, regulatory, or clinical research environments.
• Background evaluating clinical trial designs, bioequivalence data, and statistical protocols.
• Familiarity with the Federal Food, Drug, and Cosmetic (FD&C) Act, FDA guidance documents, and Good Clinical Practice (GCP) standards.
• Prior experience inside the medical device or pharmaceutical industry managing product lifecycles, clinical outcomes, or postmarket safety data.
• Ability to communicate well with others using excellent written and verbal communication skills.
• Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel.
• Proficiency with Microsoft Office Suite (Outlook, Word, Excel, etc.).
• Must be a US Citizen or Full Green Card holder.

Nice To Haves

• An advanced degree (MD, MS, PhD) in a related/applicable field is strongly preferred.
• Advanced degrees can substitute for professional work experience.

Responsibilities

• Review INDs, NDAs, BLAs, PMAs, and 510(k)s to assess how drug/biologic and device components interact.
• Consult with cross-center experts (CDER, CDRH, CBER) and the Office of Combination Products to ensure aligned, consolidated regulatory feedback.
• Assess design controls, human factors (usability), and essential drug delivery outputs for complex combination therapies.
• Advise sponsors in pre-submission meetings and help develop or implement agency guidance documents, under the direction of federal personnel.
• Draft formal deficiency letters for manufacturers if additional non-clinical, clinical, or manufacturing data is required.

Benefits

• Employee-owned company
• Consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior