Combination Product (Medical Device) Reviewer

About the Role

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, specific to 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). This candidate should possess specific expertise and applicable training in regulatory scientific review, as relevant to: evaluating medical device investigations and clinical data to support regulatory decisions; ensuring clinical trial designs, biostatistics, and real-world evidence (RWE) comply with human subject protection standards and safety regulations before devices reach the market.

Key Duties and 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.
• Under direction of federal personnel, advise sponsors in pre-submission meetings and help develop or implement agency guidance documents.
• Draft formal deficiency letters for manufacturers if additional non-clinical, clinical, or manufacturing data is required.

Qualifications

• Bachelor's degree (BS) in a relevant field required; an advanced degree (MD, MS, PhD) in a related/applicable field is strongly preferred.
• 5-7 years of applicable experience required; advanced degrees can substitute for professional work experience.
• 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.
• 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.).

Schedule

Monday through Friday (No Holidays).

Location

This position is 100% telework.