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.  

Learn More About This Agency: 

Become a part of the Department that touches the lives of every American. 

At the Department of Health and Human Services (HHS) you can give back to your community, state, and country, by making a difference in the lives of Americans everywhere! HHS is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans. 

The U.S. Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective; that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe; and that all such products marketed in the U.S. are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. 

The mission of the Center for Devices and Radiologocal Health (CDRH) is to protect and promote 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. CDRH provides consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the United States.  

Duties 

• Serves as the DHT4 Deputy Office Director reporting to the OHT4 Office Director, providing assistant to the Office Director and a technical authority on devices with regard to safety and effectiveness, and senior advice and leadership to scientific, clinical, professional, and technical staff throughout the Office.   
• The Deputy Office Director will also serve 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.  
• Engages regularly with internal stakeholders and 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 these submissions.   
• Provides technical and non-technical leadership to device advisory panels and panel members and consultants and provides guidance on classification actions, petitions, 510(k)s, PMAs, PDPs, De Novos, 513(g)s and IDEs with Center and Agency components or other organizations.   
• 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.   
• Makes decisions of national and international significance, which impacts the availability of and the safety and effectiveness of various medical device products.   
• Provides information and consultation to individuals, federal agencies, private industries (medical device), universities, and/or foreign governments on scientific and public health issues. 
• Represents the FDA/CDRH at national scientific conferences, multiple stakeholder committees, registry steering committees, national working groups, and/or FDA advisory panel meetings. 

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, unofficial transcripts, and a cover letter by Tuesday, October 29, 2024, to CDRHRecruitment@fda.hhs.gov. Compile the above mentioned applicant documents into one combined document (i.e., Adobe PDF). Additionally, candidates must verify U.S. Citizenship in the application e-mail. Self-declaration is acceptable. 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 their resume with “do not share”. Please include the following Job Reference ID in the subject line of your email submission: Deputy Office 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.