Jobs at the Center for Devices and Radiological Health (CDRH)
Join the CDRH Team
CDRH is committed to building a modern and diverse workforce where our employees are supported, career progression is promoted, and innovation and forward-thinking is respected.
Do you have a background in medical devices, radiation-emitting products, health-related sciences, engineering, health policy, communications, or administration. If so, we’d love to hear from you. Explore the opportunities below and see how you can make a difference by protecting and promoting the health of the American people.
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Click here to view career Opportunities at CDRH
Find Your Career Path at CDRH
We’re looking to fill a variety of roles. Where does your expertise fit? To begin planning your career path, click on the job descriptions below to learn more about the types of positions available at CDRH:
CDRH Biologists may perform duties that include, but are not limited to:
- Review and evaluate scientific and clinical data to determine the safety and effectiveness of medical products.
- Develop evaluation guidelines for new classes of products and devices.
- Review scientific data submitted in support of a variety of medical device submissions such as premarket applications (PMAs), product development protocols (POPs), applications for investigational device exemptions (IDEs), etc.
- Prepare and present scientific and technical reports and briefings for staff and other federal agencies on the history, status and future of research programs.
- Evaluate scientific data using laboratory testing protocols and test methods developed for highly complex and sophisticated devices, and descriptions of devices.
- Design and conduct experimental and theoretical studies to evaluate the performance of medical devices and radiological products.
CDRH Chemists may perform duties that include, but are not limited to:
- Obtain and review technical data and material related to scientific analysis projects, by investigation, analysis, and interpretation of the composition, physical, and chemical properties, molecular structure and chemical reactions of substances, and the prediction of performance as it relates to medical devices and radiological health products in the field of Chemistry.
- Serve as an expert technical consultant and advisor to scientific and technical personnel inside and outside the agency in the field of medical devices and radiological product analysis and methods.
- Review scientific data submitted in support of a variety of medical device submissions such as premarket applications (PMAs), product development protocols (POPs), applications for investigational device exemptions (IDEs), etc.
- Review and evaluate evidence and technical data submitted in support of the medical device submissions with respect to accuracy, precision, and reliability and makes a judgment on whether the supporting data provided are sufficient to substantiate labeled claims.
- Prepare and present scientific and technical reports and briefings for staff and other federal agencies on the history, status and future of research programs.
CDRH Data Scientists may perform duties that include, but are not limited to:
- Serve as a subject matter expert and provide administrative and technical oversight on the integration of in-depth data science knowledge into data analytic and visualization tools that will be utilized to support Office and Center leadership in making evidenced-based regulatory decisions concerning digital health devices, encompassing the entire product lifecycle.
- Provide expert guidance and share recommendations, with Team, Division, and Office leadership, on cloud-based solutions and custom software to support regulatory technology integration needs.
- Engage and educate the Digital Health Division and Office leadership on data as an integral enterprise asset within the current ecosystem and the importance of proper data governance, management, and stewardship.
- Advises the Assistant Director, Division Director, and Office leadership on the utilization of new and emerging technologies associated with artificial intelligence and machine learning in the analysis of digital health medical device data to detect early signals, trends, and other critical information that may not be visible upon routine inspection.
- Identify risks and encourage continuous improvements in data management through technological innovation and operational improvement.
- Analyzes data sets to determine their quality and informational content and cleanses them to maintain their use in regulatory analysis and decision-making.
- Forge mutually beneficial formal partnerships with medical device manufacturers, suppliers, carriers, foreign agencies, professional scientific organizations, health care community, patient advocacy groups, academia, and other federal, state, and local stakeholders.
- Apply expert knowledge of development, support, and analysis of data systems, including evaluating their effectiveness and determining appropriate enhancements to support the duties and responsibilities of the position.
- Keep abreast of evolving and state of the art regulatory policies and procedures and data/information science, data tools, and best practices.
- Drive the effort to reduce industry's administrative burden, continuously streamline technology, supporting product development, and facilitating innovation, without compromising the regulatory review process.
- Draft recommendations, most of which will be technical in nature, to describe data science activities, analysis, results, and conclusions to assist in supporting and advancing digital health medical device regulation.
CDRH Digital Health Advisors may perform duties that include, but are not limited to:
- Participate in the review and evaluation of first-of-a-kind digital health technologies and participate in precedent-setting research.
- Identify opportunities in creating preconditions and incentives informing digital health policy proposals, meeting the FDA's mission to protect and promote public health while supporting technological advances.
- Provide advice, consultations, and training to internal and external experts on current state of digital health technologies, policies, and functionalities.
- Assist with identifying and evaluating technology solutions that will enhance internal processes for FDA's Center for Devices and Radiological Health.
CDRH General Engineers may perform duties that include, but are not limited to:
- Provide general engineering expertise in dealing with engineering aspects of public health issues across the total product life cycle review of products.
- Provide General Engineering Regulatory Consultation as a technical consultant and advisor to scientific and technical personnel inside and outside the agency in a wide-ranging arena of scientific and engineering subject matters to include the field of medical devices and radiological product analysis and methods.
- Evaluate scientific and engineering data, as well as the test methods and descriptions of devices contained in medical device submissions from industry to the Agency.
- Review scientific data submitted in support of a variety of medical device submissions such as premarket applications (PMAs), humanitarian device exemptions (HDEs), product development protocols (POPs), applications for investigational device exemptions (IDEs), etc.
- Prepare and present scientific and technical reports and briefings for staff and other federal agencies on the history, status and future of research programs.
CDRH Microbiologists may perform duties that include, but are not limited to:
- Review and evaluate scientific and clinical data to determine the safety and effectiveness of medical devices.
- Develop evaluation guidelines for new classes of products and devices.
- Review scientific data submitted in support of a variety of medical device submissions such as premarket applications (PMAs), product development protocols (POPs), applications for investigational device exemptions (IDEs), etc.
- Prepare and present scientific and technical reports and briefings for staff and other federal agencies on the history, status and future of research programs.
- Evaluate scientific data using laboratory testing protocols and test methods developed for highly complex and sophisticated devices, and descriptions of devices.
- Design and conduct experimental and theoretical studies to evaluate the performance of medical devices and radiological products.
CDRH Physicians may perform duties that include, but are not limited to:
- Serve as a clinical expert providing leadership and guidance on medical devices, regulatory science, and policies and procedures associated with technology innovation as well as digital health medical devices.
- Participate in the review and evaluation of first-of-a-kind digital health technology and in precedent-setting research.
- Participate in the review of investigational device exemptions (IDEs), premarket applications (PMAs), 510(k)s, humanitarian device exemptions (HDEs), pre-IDEs, etc.) applications for new technologies, to new types of devices and combination products.
- Complete data analysis on clinical reports and integrates data derived from medical literature, FDA adverse experience reports, material submitted to FDA on similar or analogous substances, results of field surveys by FDA District Offices and consults with authorities in the pertinent fields.
- Serve as a clinical authority on the latest developments in health care policy and the medical device industry.
Join CDRH at an Upcoming Recruitment Event
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.
Hiring people with diverse backgrounds and experiences isn’t just the right thing to do. It’s the smart thing to do. It helps us to best fulfill our mission to protect and promote public health.
We’ve expanded our outreach, recruitment, and involvement with organizations to increase our ability to attract a diverse cadre of highly qualified candidates. To learn more, join us at an upcoming outreach or recruitment event and see why we are an FDA-center of choice.
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