Physician (Orthopedic Surgeon)

Summary:

The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) and being filled under FDA’s Title 21 hiring authority. This hiring authority was passed by Congress in December 2016, to improve FDA’s ability to recruit and retain scientific, technical, and professional experts in certain occupational series that “support the development, review, and regulation of medical products.” The FY23 Omnibus Appropriations Bill expanded the hiring authority to include cross-cutting positions and individuals that support the development, review, and regulation of food and cosmetics in addition to medical products. Both statutes amended the FD&C Act 21 USC. This hiring authority is a streamlined hiring authority, outlined in 21 USC 379d-3a, as amended by the 21st Century Cures Act of 2016, § 3072 and the Consolidated Appropriations Act of 2023, § 3624.

This job is open to: Open to the Public

Note: Traditional federal rules regarding rating, ranking, and veterans' preference do not apply.

Duties

**This is a full-time position**

Reporting directly to the Assistant Director, the Physician (Orthopedic Surgeon) will serve as a clinical authority and technical expert for the review of cutting-edge orthopedic medical devices, implants, techniques, instrumentation, and surgical systems and will play a pivotal role in advancing the mission of the Center’s Total Product Lifecycle Advisory Program (TAP). TAP is designed to spur rapid development and wide-spread use of “breakthrough” lifesaving and health improving medical devices and products, support patient access and ensures the safety, effectiveness, and reliability of these products throughout the total product lifecycle. The Physician will lead solution-focused engagement activities with medical device developers, members of the healthcare and standards communities, patients, and patient advocacy organizations, and other non-FDA stakeholders to ensure timely and sustainable patient access

to these critical devices. Additionally, the incumbent will serve as an advisor to the Office Director, Super Office Director, and other OPEQ Offices, as well as CDRH leadership. Further,

the incumbent will provide advice and leadership to scientific, clinical, professional, and

technical staff throughout OHT 6, regarding orthopedic medical devices and systems. The Physician will also perform the following duties:

• Serve as an authority on the latest developments in health care policy and the orthopedic medical device industry. As such, conducts regulatory policy reviews related to the development aspects of orthopedic medical devices, diagnostic equipment, surgical instrumentation, and systems used in this medical device space.
• Provide oral and written consultations for various types of regulatory submissions across a wide range of orthopedic medical device types related to fracture fixation, joint replacement, reconstruction, trauma, sports medicine, limb lengthening, and disorders of the spinal, hand, and upper and lower extremities.
• Foster patient partnerships with capabilities to collaborate with MedTech industry sponsors, innovators, and FDA to provide insights on unmet needs, disease burden, real world experiences and preferences within the target patient population.
• Utilize clinical expertise and technical knowledge to serve as an authoritative voice and principal advisor to OHT 6 Assistant Directors and the OHT6 Office Director on matters regarding orthopedic medical devices, diagnostic equipment, instrumentation, surgical systems, and products, encompassing the entire product lifecycle.
• Provide authoritative analysis of the scientific data submitted in orthopedic medical device regulatory submissions and assists in the interpretation of post-market adverse event data.
• Offers evidence-based recommendations regarding classification and petitions for the reclassification of new orthopedic medical devices, instrumentation, and systems, as well as identifies areas where standards need to be developed and/or revised.

How to Apply:

**This is a full-time position**

Submit an electronic resume or CV, cover letter containing a brief summary of scientific accomplishments, SF-50 (if applicable), and a copy of unofficial transcripts in one document (Adobe PDF) to CDRHRecruitment@fda.hhs.gov, with Job Reference code “2024-OHT6-Physician” in the subject line. Applications will be accepted through Wednesday, December 18, 2024.

Please follow all instructions carefully. Errors or omissions may affect your eligibility.