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), Office of Product Evaluation and Quality (OPEQ), Office of Health Technology IV (OHT4) 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 

Hiring Path Clarification Text: You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a 21st Century Cures Act authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply. 

Duties 

• Serves as the Chief Medical Officer (CMO) and as an Associate Director. In this capacity, the incumbent will serve as the Office’s senior clinical advisor and program manager regarding the total product lifecycle review of in-scope surgical medical devices, infection control products and personal protective equipment, and any associated clinical concerns.   
• Serving as a recognized expert, the CMO will provide clinical consultation to the Office Director , staff, colleagues across the Center, as well as CDRH and Agency leadership.   
• As the Associate Director, the incumbent will advise Office leadership on trends noted in the clinical, patient, and scientific communities, as well industry regarding significant concerns and reported adverse event data related to general surgery, plastic and reconstructive surgery, and infection control medical devices and products regulated by the Center.  
• As a recognized clinical and surgical expert, the incumbent will collaborate with colleagues across the Office, as well as Center and Agency leadership to develop guidance documents, policies, and standards regarding the regulatory oversight of clinical trials and the use of clinical outcome assessments in the evaluation of general surgery, plastic and reconstructive surgery, and infection control medical devices and products regulated by the Center.  
• Serves as the clinical authority in reviewing and evaluating clinical, surgical, and research findings, scientific properties, analyses, laboratory and clinical behavior, and the impact of these factors and properties on the safety and effectiveness of in-scope medical devices and infection control products.  
• Evaluates the effectiveness of existing research support in relation to the Office’s programs requirements. As such, the incumbent will develop or modify research plans as required to meet Office needs and coordinate activities and actions in this area with the Office of Science Engineering and Laboratories (OSEL), the Office of Clinical Evidence and Analysis (OCEA), and the FDA’s Oncology Center of Excellence (OCE).   
• Serves as the Office focal and primary point of contact for medical device clinical and surgical issues and provides expert and authoritative advice, guidance, assistance, interpretations, consultations, and recommendations to Office staff , as well as Center and Agency officials.  
• Drafts decisions and recommendations of national public health significance, which may impact the availability of certain products due to safety, efficacy, manufacturing, and reliability concerns. 
• Provides briefings and recommendations to senior and executive level Agency and Departmental officials. 
• Proposes, writes, evaluates and explains product review and other medical guidelines or criteria concerning the data in applications submitted to the Agency for the review and approval of medical devices proposed for either investigational purposes or general marketing. 

How to Apply:  

Submit resume or curriculum vitae, cover letter with a brief summary of accomplishments, SF-50 (if applicable) and a copy of unofficial transcripts in one document (Adobe PDF) to CDRHRecruitment@fda.hhs.gov, by Monday, December 30, 2024. Please include the following Job Reference ID in the subject line of your email submission: Chief Medical Officer (Associate Director) - (OHT4/IO) – Last Name, First Name 

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply to this announcement. Officers must follow the instructions for how to apply and include their most recent orders in addition to the required documents. If selected, candidates will be referred to (CC) personnel and not as candidates for a Cures appointment.