This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. Additional information on 21st Century Cures Act can be found here: 

21st Century Cures Act Information 

Introduction 

The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective. 

The mission of the Center for Devices and Radiological Health (CDRH or Center) is to protect and promote the public health by performing essential public health tasks by making sure that medical devices and radiological health products are safe for people in the United States. The Office of Product Evaluation and Quality (OPEQ) assures patients have access to high quality, safe and effective products throughout the total product lifecycle by implementing program areas through which medical devices are evaluated or cleared for clinical investigations and Marketing. The Office of Health Technology V (OHT5 or Office) is responsible for the total product lifecycle (TPLC) review of neurological and physical medicine devices. 

Meet one of the faces behind CDRH here. 

Duties/Responsibilities 

Reporting directly to the OPEQ Office Director, the Deputy Office Director will serve as an assistant to the Office Director and a technical authority on devices with regard to safety and effectiveness. Also, the incumbent provides senior advice and leadership to a scientific, clinical, professional, and technical staff throughout the Office.  

The Deputy Office Director also performs the following duties: 

• Serves as the technical authority and principal advisor to the Office Director on the total product lifecycle of devices including premarket evaluation, compliance and quality, and surveillance programs.  
• Develops and sustains strategic relationships with internal stakeholders and key external stakeholders such as the medical device industry, trade associations, other Federal agencies, other countries, State agencies, and the general public. 
• Oversees medical device reviews and the decision-making process on classifications, petitions, 510(k)s, HDEs PMAs, PDPs, De Novos, 513(g)s, IDEs, and all supplements and amendments to the submissions. 
• Oversees medical and healthcare compliance activities including inspection, classification, recall classification, labeling review, import alerts, custom device reports and surveillance activities including MDR review and analysis, 522 Studies, PAS studies. 
• Develops and implements policies and plans in relation to the Office, OPEQ and Center goals and federal budgetary and economic realities. 
• Makes assessments, in coordination with the OPEQ Director and evaluation of operations/priorities. 

Supervisory Responsibilities: Direct a multi-disciplinary program, providing leadership and management oversight to subordinate support staff and division directors in the absence of, and in accordance with the Office Director. Plans, assigns, oversees, and directs the work to be accomplished, ensuring timely performance of a satisfactory amount and quality of work; sets and adjusts priorities and timeframes for completion of the work; provides advice and guidance to staff members; reviews work products and accepts, amends or rejects work; develops performance standards and serves as rating official on employee evaluations. Gives advice, counsel, or instruction to employees on both work and administrative matters. Interviews candidates for positions in the Division; recommends appointment, promotion or reassignment of such positions; hears and resolves complaints from employees, referring group grievances and more serious unresolved complaints to a higher-level supervisor or manager; effects minor disciplinary measures, such as warnings and reprimands, recommending other action in more serious cases; identifies developmental and training needs of employees; providing or arranging for needed development and training, finds way to improve productivity or increase the quality of work directed; develops performance standards. 

How to Apply 

Submit resume or curriculum vitae and transcripts, with cover letter by Wednesday, May 29, 2024, 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: Deputy Office Director (OHT5/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. 

Announcement Contact 

For questions regarding this Cures position, please contact CDRHRecruitment@fda.hhs.gov. 

The Department of Health and Human Services is an equal opportunity employer with a smoke free environment. 

FDA is an equal opportunity employer.