Regulatory Cybersecurity Specialist
What you'd do
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 2, Band D.
Major duties
Develops and implements cybersecurity legislation, policies, guidance documents, and white papers to establish and advance cybersecurity requirements for medical devices. Ensures requirements address key areas including risk management, secure architectures, security controls, secure update mechanisms, software bill of materials (SBOM), coordinated vulnerability disclosure (CVD) and other controls as identified. Supports the development and implementation of a cybersecurity strategic plan and roadmap. Incorporates lessons learned and continuously re-evaluates cybersecurity policy to ensure the Center's frameworks evolve in response to emerging cybersecurity challenges. Reviews, analyzes, and assesses proposed initiatives, agreements, and legislation from other organizations and governments to determine the feasibility of FDA participation and identify potential conflicts with FDA's regulatory mandates. Provides expert recommendations on the impact of external proposals on FDA's cybersecurity program. Provides routine cybersecurity incident and vulnerability response Provides expert consultation and recommendations of cybersecurity implementation to premarket submissions as needed Active in industry discussions and working groups to support cybersecurity of medical devices Other duties as assigned
What you need to qualify
In order to qualify for the Regulatory Cybersecurity Specialist position which falls under the 0301 occupational Series, you must meet the following requirements by 11:59 pm EST on 09/01/2026: Basic Qualification Requirements: Education: A bachelor's degree or higher in a science, technology, engineering, mathematics, computer science, statistics, or software engineering. The degree must be from an accredited program or institution. OR Experience: Comparable work in digital health policy, digital health technology support, digital health training, medical device cybersecurity, artificial intelligence/machine learning, regulatory science advancement, regulatory review support and coordination, advanced manufacturing, real world evidence and advanced clinical studies, regulatory innovation, or digital health strategic partnership Minimum Qualifications: Comparable experience is experience that equipped the applicant with the knowledge, skills, and abilities to perform successfully the duties of the position, and that is typically in or related to the work of the position to be filled. The relevant experience must demonstrate one year of full-time work experience, or the equivalent if part-time (for example, an employee working 20 hours per week for a 12-month period should be credited with 6 months of experience). Experience may have been obtained in either the federal service or its equivalent with state or local government, the private sector, or nongovernmental organizations. IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS. Have a bachelor's degree and 5 years of comparable experience demonstrating understanding in cybersecurity vulnerability analysis, operational technology, information technology, information management, or a related field. OR Have a master's degree and 4 years of comparable experience demonstrating understanding in cybersecurity vulnerability analysis, operational technology, information technology, information management, or a related field. OR Have a Doctorate and/or J.D. degree and 2 years of comparable experience demonstrating understanding in cybersecurity vulnerability analysis, operational technology, information technology, information management, or a related field. OR Have a MD/DO/DDS/DPM/DVM degree and 2 years of comparable experience demonstrating understanding in cybersecurity vulnerability analysis, operational technology, information technology, information management, or a related field. OR Have 7 years of comparable experience demonstrating understanding in cybersecurity vulnerability analysis, operational technology, information technology, information management, or a related field. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
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