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 Center for Devices and Radiological 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 facilitates 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 U.S.
This position(s) is located in CDRH’s Office of Clinical Evidence and Analysis (OCEA), Division of Clinical Evidence and Analysis 1, Clinical Evidence Outcomes Research Team (DCEA1-8). OCEA provides policy and program support regarding clinical trials, biostatistics, real-world evidence, epidemiological analysis and outreach and collaboration with hospitals and other external stakeholders. OCEA provides:
- Policy and program support for clinical evidence and human subject protection and regulatory oversight of medical device clinical investigations, good laboratory practice, and good clinical practice in support of premarket review.
- Biostatistical and epidemiologic analyses, as well as support in the development of data infrastructure and expertise on clinical investigations and real-world evidence.
We invite you to listen as a CDRH employee talks about his passion for the work he does, the Agency’s pioneering regulatory science culture and opportunities for professional growth, and why he loves working at FDA by clicking here.
This position(s) is located in CDRH’s Office of Clinical Evidence and Analysis (OCEA), Division of Clinical Evidence and Analysis 1, Clinical Evidence Outcomes Research Team (DCEA1-8). As a Health Scientist in CDRH you will:
- Plan, direct, and review the technical evaluation and research of the team in all areas of medical device and radiation-emitting electronic products;
- Lead the team in the determination of the adequacy of information submitted and the thoroughness of data contained in scientific protocols, findings of studies or medical device evaluations submitted to the Agency by the regulated industry;
- Collaborate and prepare comprehensive, concisely written reviews regarding scientific protocols, findings of studies or medical device evaluations; and
- Plan, coordinate, and evaluate the program activities of the team.
Applicants will be required to meet the specific qualification requirements of the following occupational series: General Medical and Healthcare Series, 0601
Additionally, applicants must possess the required specialized experience that equipped them with the particular knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled.
Applicants must have one year (52 weeks) of specialized experience equivalent to the GS-13 grade level in the Federal service, experience includes:
- Reviewing quality, clinical, scientific, and other data in support of a variety of medical device and radiological health programs;
- Advising on the adequacy of research study documentation, protocols, epidemiologic methodologies, data analyses, medical device evaluation and/or interpretations of results; and
- Managing, directing or overseeing the work of a team or working group or leading a project.
NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Please see the official job vacancy announcement for: additional information; additional specialized experience, education and qualification requirements.
The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.