Description

Title 21 Vacancy Announcement

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Center for Devices and Radiological Health (CDRH)

Office of Product Evaluation and Quality (OPEQ)

Office of Health Technology V (OHT5)

Application Period: Tuesday, April 30, 2024, through Wednesday, May 29, 2024

Area of Consideration: United States Citizenship is required. You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration.

Position: Deputy Office Director Series: Biologist (0401); Microbiologist (0403); Physician (0602); General Engineer (0801); Mechanical Engineer (0830); Electrical Engineer (0850); Biomedical Engineer (0858); General Health Scientist (0601)

Location(s): Remote Eligible Salary: Salary is commensurate with education and experience and starts at $181,551.00

Work Schedule: Full-Time

Cures Band(s): Band F Full Performance Band Level: Band F

Travel Requirements: This position requires Supervisory: Yes

up to 25% of travel

Bargaining Unit: 8888

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 OHT5 Office Director, the Deputy Office Director will serve as an assistant to the Office Director and a technical authority on devices regarding 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.