General Health Scientist

Food and Drug Administration • Silver Spring, MD

29d

About The Position

This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority. This position is being recruited based on the Title 21 Pay Table 1, Band D.

Requirements

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.
• The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service.
• Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice.
• FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
• Males born after December 31, 1959, must be registered with the Selective Service.
• Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
• Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
• Probationary periods are required for new employees appointed to competitive service positions for the first time; or reinstated employees who return after a break in service of 30-days or more and who have not completed a probationary period.
• Basic Qualification Requirement: Education: Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.
• Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
• Have a Bachelor's degree and have five (5) years of comparable experience leading independent quality assessments, audits, and compliance evaluations of CDRH review activities, applying authoritative judgment to identify opportunities for improvement, deficiencies, develop corrective action recommendations, and track findings through closure in alignment with quality management standards and FDA regulatory requirements.
• Have a Master's degree and have four (4) years of comparable experience leading independent quality assessments, audits, and compliance evaluations of CDRH review activities, applying authoritative judgment to identify opportunities for improvement, deficiencies, develop corrective action recommendations, and track findings through closure in alignment with quality management standards and FDA regulatory requirements.
• Have a Doctorate/or JD degree and have two (2) years of comparable experience leading independent quality assessments, audits, and compliance evaluations of CDRH review activities, applying authoritative judgment to identify opportunities for improvement, deficiencies, develop corrective action recommendations, and track findings through closure in alignment with quality management standards and FDA regulatory requirements.
• Have a MD, DO, DDS, DPM, or DVM degree and have two (2) years of comparable experience leading independent quality assessments, audits, and compliance evaluations of CDRH review activities, applying authoritative judgment to identify opportunities for improvement, deficiencies, develop corrective action recommendations, and track findings through closure in alignment with quality management standards and FDA regulatory requirements.
• You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned.
• Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications.
• If you are using education completed in foreign colleges or universities, 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.
• Candidates should be committed to improving the efficiency of the Federal government, passionate about the ideals of our American republic, and committed to upholding the rule of law and the United States Constitution.

Nice To Haves

• If you are serving, or have served in the last 5 years (from 10/16/2026 ) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment.

Responsibilities

• Leads independent quality and technical reviews of submissions to assess the quality, completeness, and compliance of submissions in accordance with applicable procedures, regulations, and CDRH guidance documents.
• Leads audits and assessments of post-market surveillance review activities and documents findings to identify trends or deficiencies that may indicate systemic quality issues within CDRH's review programs.
• Reviews medical device product activities with broad coordination across CDRH to assess alignment with established quality management standards, regulatory requirements, and applicable operating procedures and regulations.
• Applies advanced health science knowledge and regulatory expertise to assess the adequacy of CDRH review activities, methodologies, and procedures, identifying areas where review quality may be strengthened or where deviations from established standards have occurred.
• Independently reviews and evaluates CDRH premarket and post-market review decision activities to ensure consistency with applicable statutory requirements, FDA guidance, and established review standards.
• Applies expert knowledge of medical device classification, regulatory pathways (including 510(k), De Novo, PMA, and HDE), and applicable performance standards to evaluate and provide senior-level guidance on the regulatory determinations made during CDRH review activities.
• Collaborates with and provides senior-level guidance to CDRH review staff and program offices to gather information necessary to conduct quality assessments of regulatory review activities, ensuring that findings are grounded in an accurate and comprehensive understanding of the scientific and regulatory context of each review area.
• Independently leads quality assessments and compliance evaluations of CDRH's core, organizational, and enabling processes to determine conformity with internal quality management standards, ISO 9001:2015 requirements, and applicable FDA regulations and policies.
• Leads continuous process improvement (CPI) initiatives by independently identifying inefficiencies in CDRH review and compliance processes, developing evidence-based solutions, and directing the implementation and evaluation of process changes in collaboration with relevant stakeholders.
• Leads and participates in cross-functional working groups and committees focused on quality management, regulatory review improvement, and operational excellence, contributing authoritative subject matter expertise in health science and regulatory compliance.

Benefits

• A career with the U.S. government provides employees with a comprehensive benefits package.
• As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding.
• Eligibility for benefits depends on the type of position you hold and whether your position is full-time, part-time or intermittent.
• Contact the hiring agency for more information on the specific benefits offered.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior