Application Period: November 8, 2021 through December 7, 2021
Salary: Salary is commensurate with education and experience.
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 CDRH 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. OCEA is dedicated to providing policy and program support regarding clinical trials, biostatistics, real-world evidence, epidemiological analysis, and outreach and collaboration with hospitals and other external stakeholders.
Position Summary: As a General Engineer (Staff Fellow) in OCEA’s Division of Clinical Evidence and Analysis 1 (DCEA1), you will provide policy and program support regarding oversight of clinical evidence-related programs such as the Breakthrough Devices Program, Safer Technologies Program, and Investigational Device Exemption (IDE) Program..
Duties/Responsibilities: The General Engineer (Staff Fellow) also performs the following duties:
Provide advice on the interpretations of the laws, regulations, and policies applicable to the Center and FDA related to these programs.
Make major recommendations and decisions related to policy formulation in connection with prospective changes in programs and policies as the result of new interpretations of existing laws, and/or significant developments in the medical device industry, specifically related to clinical evidence related programs.
Serve as an authoritative expert in analyzing legislation and developing standards, guidance, regulations, or policies that impact clinical evidence-related programs such as the Breakthrough Devices Program, Safer Technologies Program, and Investigational Device Exemption (IDE) Program.
Develop regulations, and policies involving complex and high priority matters affecting these programs.
Draft or critically review documents related to these policy proposals and decisions of these programs, including regulations, citizen petition responses, guidance, proposed legislation, and policy statements.
Basic Qualifications: Applicants must meet the specific qualification requirements of the following applicable occupational series: General Engineering (0801).
Required Specialized Experience and Qualifications: To qualify for this position, you must demonstrate in your resume the necessary qualifying experience for this position, which is equivalent to the following:
Advising on compliance and/or regulatory policy developments
Preparing and presenting briefings to senior level management and recommending program enhancements; and
Developing, modifying, and/or evaluating guidelines concerning data required in products such as medical devices and/or radiological products.
Collaborating with other scientists, engineers, and/or healthcare professionals within an organization/agency on a wide range of scientific and regulatory issues.
Additional Qualifications: To qualify as a Staff Fellow, you must: be a US Citizen, Permanent Resident, or Non-Citizen with residency status in the U.S., three (3) out of the last five (5) years; possess a doctoral-level degree from an accredited institution of higher learning, including: Ph.D., M.D., D.V.M., D.D.S., D.M.D., Sc.D., or other research doctoral-degree widely recognized in U.S. academe as equivalent to a Ph.D.. (In limited instances non-doctoral candidates, and/or candidates with less experience may be acceptable).
This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office.
How to Apply: Prior to applying, please see the following instructions:
Documents to submit: electronic resume or curriculum vitae, cover letter describing why you are uniquely qualified for this, and copy of transcripts
Compile all applicant documents into one combined document (i.e. Adobe PDF)
Include Job Reference code “DCEA1 General Engineer” in the email subject line.
HHS/FDA is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
About FDA - Center for Devices and Radiological Health (CDRH)
The world renowned U.S. Food and Drug Administration (FDA), is a government agency that is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The Center for Devices and Radiological Health (CDRH), part of the U.S. Food and Drug Administration (FDA), assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide 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 U.S. FDA is an equal opportunity employer and encourages applications from a diverse pool of high quality candidates. FDA offers its employees a wide array of benefits.
At CDRH our employees are our most valued resource. ...We treasure individual excellence, teamwork, and personal and professional diversity. Our goal is to cultivate a high-performing, diverse, and inclusive workforce based on mutual acceptance and trust.
If you are interested in leading the way in medical excellence, please click on the links to apply to the positions.