Combination Product (Medical Device) Reviewer

The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe 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 regarding clinical trials, biostatistics, real-world evidence, epidemiological analysis and outreach and collaboration with hospitals and other external stakeholders.

Tunnell Government Services, Inc. is providing professional and scientific services to CDRH with expert consultants with scientific expertise in the regulation and approval and of medical devices. In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; write detailed documents and reports; and execute other administrative tasks related to CDRH's projects.

Tunnell is seeking a candidate to provide expert consulting services to assist the 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

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

Qualifications

• The candidate must possess a bachelor's degree (BS) in a relevant field
• An advanced degree (MD, MS, PhD) in a related/applicable field is strongly preferred.
• 5-7 years of applicable experience is required, however advanced degrees can substitute for professional work experience
• Candidates must demonstrate advanced professional experience in scientific, regulatory, or clinical research environments. Key background experiences include:
  • Trial Evaluation: Background evaluating clinical trial designs, bioequivalence data, and statistical protocols.
  • Regulatory Knowledge: Familiarity with the Federal Food, Drug, and Cosmetic (FD&C) Act, FDA guidance documents, and Good Clinical Practice (GCP) standards.
  • Industry Experience: 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.)

Job Type: Full Time

Schedule: Monday through Friday (No Holidays)

Location: This position is 100% telework.

Must be a US Citizen or Full Green Card holder.