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 C.

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.
• You must meet ALL requirements by the closing date of this announcement to be considered.
• Only education, experience, and qualifications attained by this date will be considered.
• You must continue to meet all requirements through the hiring process.
• 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.
• Have a bachelor's degree and have 4 years of comparable experience conducting quality and technical reviews of medical device regulatory review activities, evaluating compliance with quality management standards and FDA regulatory requirements. This includes experience performing audits, identifying nonconformities, monitoring corrective actions, analyzing data to identify trends and process improvement opportunities.
• Have a master's degree and have 3 years of comparable experience conducting quality and technical reviews of medical device regulatory review activities, evaluating compliance with quality management standards and FDA regulatory requirements. This includes experience performing audits, identifying nonconformities, monitoring corrective actions, analyzing data to identify trends and process improvement opportunities.
• Have a Doctorate and/or J.D. degree and have 1 year of comparable experience conducting quality and technical reviews of medical device regulatory review activities, evaluating compliance with quality management standards and FDA regulatory requirements. This includes experience performing audits, identifying nonconformities, monitoring corrective actions, analyzing data to identify trends and process improvement opportunities.
• Have a MD, DO, DDS, DPM, or DVM degree.
• Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
• Applicants selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring.

Nice To Haves

• 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.

Responsibilities

• Conducts quality and technical reviews of assigned premarket and post-market regulatory submissions to evaluate completeness, consistency, and compliance with applicable statutes, regulations, FDA guidance documents, and CDRH standard operating procedures.
• Reviews assigned medical device regulatory review activities and coordinates with CDRH offices to obtain information necessary to evaluate review documentation, processes, and compliance with applicable quality management standards, operating procedures, and regulatory requirements.
• Applies professional knowledge of health science, medical device regulation, and quality management principles to evaluate assigned review activities, methodologies, and documentation for consistency with established standards.
• Applies knowledge of medical device classification, regulatory pathways, including 510(k), De Novo, PMA, and HDE submissions, and applicable regulatory requirements when evaluating assigned regulatory review activities and supporting documentation.
• Collaborates with CDRH review staff and program offices to obtain technical information necessary to complete assigned quality assessments and ensure observations accurately reflect the scientific and regulatory context of the review activities evaluated.
• Conducts quality assessments of assigned organizational processes to evaluate conformance with CDRH's Quality Management System, ISO 9001:2015 requirements, applicable FDA regulations, and established procedures.

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.

What This Job Offers

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