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 Clinical Evidence and Analysis (OCEA), 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. 

Duties 

• Oversees the consistent application of policy, regulatory guidance, analysis, interpretation, and programmatic support within the Division to other parts of OCEA, OPEQ, and CDRH. 
• Develops and implement policies and plans that are sound and feasible in relation to OCEA, OPEQ, and Center goals. 
• Assists in the oversight of DCEA2 regulatory and scientific work, including developing policy and program support regarding clinical evidence. 
• Serves as a technical expert and resource for team(s) to provide expertise, direction, and feedback to staff on policies and program support within one or more regulatory program areas. 
• Oversees team members and subject matter experts that provide consultative support on real-world data to other CDRH offices involved in the total product life cycle of medical device review. 
• Leads multistakeholder collaboration and engagement with the Offices of Health Technology, academia, professional societies, patient groups, industry, federal partners, and real-world evidence data coordinating centers with the goal of novel evidence generation. 

Supervisory Responsibilities: 

• Provides signatory authority on novel or complex issues and provides supervisory review for work products addressing regulatory policies, processes, and tools. 
• Plans work to be accomplished by subordinates, sets and adjusts short-term priorities, and prepares schedules for completion of work. 
• Assigns work to subordinates based on priorities, using selective consideration of the difficulty and requirements of assignments and the capabilities of employees. 

How to Apply 

Submit resume or curriculum vitae, unofficial transcripts, and a cover letter by January 5, 2025, to CDRHRecruitment@fda.hhs.gov. Compile all applicant documents into one combined document (i.e., Adobe PDF). Candidate resumes may be shared with hiring official within the CDRH with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. Please include the following Job Reference ID in the subject line of your email submission: OCEA/DCEA2 – Supervisory Epidemiologist (Assistant Director) – Clinical Evidence Outcomes Research – 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.