The FDA’s Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of In Vitro Diagnostics and Radiological Health, Division of Immunology & Hematology Devices recruiting to fill a Senior Science Reviewer position.
OIR is responsible for classifying all medical devices into Class I (General Controls), Class II (Performance Standards) or Class III (Pre-market Approval) and performing and coordinating the review of pre-market approval applications, reclassification petition requests, product development protocols, investigational device exemptions, and pre-market notifications for approval or disapproval where appropriate. In addition, OIR is responsible for all post-market activities associated with in vitro diagnostic devices under the Total Product Life Cycle system developed by CDRH. This position will be filled through FDA’s Staff Fellowship Program.
RESPONSIBILITIES: The selected candidate will review scientific data to determine the safety and efficacy of medical devices by evaluating the data, as well as the test methods and descriptions of devices contained in medical device submissions from industry to the agency and provide reports of evaluations. Serve as an expert consultant and advisor to scientific and technical personnel, inside and outside the agency, in a wide-ranging arena of scientific subject matters. Research and evaluate policy issues that are central to the mission of the center in the area of biology and design and conduct experimental and theoretical studies to evaluate the performance of medical devices and radiological products. Assess the safety and effectiveness of medical devices in support of FDA regulatory programs through direct product testing and review of data.
BASIC QUALIFICATIONS: This position is multidisciplinary, and applicants will be required to meet the specific qualification requirements of the applicable occupational series below.
Clinical Laboratory Science Series, 0644: A Bachelor’s or graduate/higher level degree from a regionally accredited college/university including courses in biological science, chemistry and mathematics, AND successful completion of a Medical Laboratory Scientist/Clinical Laboratory Scientist program accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.
Electrical Engineering Series (0850): Degree: Engineering. To be acceptable, the program must: (1) lead to a bachelor’s degree in a school of engineering with at least one program accredited by ABET; or (2) include differential and integral calculus and courses (more advanced than first-year physics and chemistry) in five of the following seven areas of engineering science or physics: (a) statics, dynamics; (b) strength of materials (stress-strain relationships); (c) fluid mechanics, hydraulics; (d) thermodynamics; (e) electrical fields and circuits; (f) nature and properties of materials (relating particle and aggregate structure to properties); and (g) any other comparable area of fundamental engineering science or physics, such as optics, heat transfer, soil mechanics, or electronics; -- OR --
Combination of education and experience -- college-level education, training, and/or technical experience that furnished (1) a thorough knowledge of the physical and mathematical sciences underlying engineering, and (2) a good understanding, both theoretical and practical, of the engineering sciences and techniques and their applications to one of the branches of engineering.
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 a lower level of education and/or experience may be acceptable).
REQUIRED SPECIALIZED EXPERIENCE: Candidates must have exceptional experience in one or more of the following areas:
Automated cell imaging analysis and interpretation; training and validation of artificial intelligence and/or machine learning software algorithms
Advanced high-complexity coagulation testing, e.g. molecular-based coagulation testing, thromboelastography and platelet function testing
Neutralizing antibody assay development and validation
In addition, candidates must have experience developing, validating, or standardizing assays for clinical trials or a clinical laboratory. Scientific knowledge and experience necessary to evaluate the accuracy, precision, and/or reliability of medical devices. Ability to: evaluate data and information from a variety of sources as well as the ability to identify and validate underlying causes, anticipate ancillary problems, and suggest appropriate courses of action regarding data assessment; identify applicable information regarding scientific and regulatory activities and policies that protect human health as well as possess the knowledge required to participate in the development and implementation of regulations and policies pertaining to medical device submissions. Additionally, candidates must be able to communicate technical issues to colleagues and customers with a variety of backgrounds.
FOREIGN EDUCATION: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation.
SALARY: Salary is commensurate with education and experience.
LOCATION: Silver Spring, Maryland
CONDITIONS OF EMPLOYMENT: The appointment is for up to two years with opportunities for renewal. No previous Federal experience is required. Appointment does not confer any entitlement to a position in the competitive service, and there is no entitlement to Merit Systems Protection Board (MSPB) appeals rights.
If applicant is an U.S. Citizen, males born on, or after, December 31st, 1959 must be registered with the Selective Service System or have an approved exemption. Visit SSS.gov for more info.
Prohibited financial interest restrictions may apply. For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office.
HOW TO APPLY: Submit electronic resume or curriculum vitae, cover letter containing a brief summary of scientific accomplishments, and copy of transcripts to CDRH-OHT7-Opportunities@fda.hhs.gov with the subject line of “Sr. Science Reviewer-ASCP-002”. Applications and all supporting documentation will be accepted through June 11, 2020.
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.
DEPARTMENT OF HEALTH AND HUMAN SERVICES IS AN EQUAL OPPORTUNITY EMPLOYER SMOKE FREE ENVIRONMENT
Internal Number: Sr. Science Reviewer-002
About Food & Drug Administration / 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.
If you are interested in leading the way in medical excellence, please click on the links to apply to the positions.