This position is being filled under a stream-lined hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.
Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act
Introduction
The Food and Drug Administration (FDA or Agency) is the regulatory, scientific, public health and consumer protection agency responsible for ensuring all human and animal drugs, medical devices, cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, tobacco and radiation emitting devices safe, and effective.
The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health by performing essential public health tasks by making sure that medical devices and radiological health products are safe for people in the United States. The Office of Strategic Partnerships and Technology Innovation | FDA (OST) provides leadership for all scientific collaborative and emerging technology related activities at CDRH. We represent CDRH with a broad and diverse array of national and international entities including other government agencies, Congress, industry, academia, consumer and patient organizations, and healthcare professional organizations, with mutual interests in medical devices and radiation-emitting products.
Duties/Responsibilities
The incumbent applies new methods and approaches incorporating state-of-the-art theories and applications. Heads projects expanding emerging best practices and advances in technology with responsibility for gathering information, identifying, and analyzing issues, and making recommendations through development of detailed plans identifying goals, objectives, and milestones.
Manages resources that provide CDRH and its information technology (IT) partners with delivery and project support services to help CDRH implement, operate, and optimize current and future technology systems, processes, and procedures. Recommendations regularly involve impact assessments of how planned computer systems upgrades can best be incorporated into organizational and process design. Performs business and systems analysis to identify business opportunities, defining detailed technical and business process requirements, including adoption and implementation of current and emerging best practices and applicable technology. Identifies unprecedented alternative approaches expanding past practice. Defines, maintains, and manages system requirements, and maintains requirements traceability. Heads development of Level of Effort (LOE) estimates for requirements analysis work, participating in the planning for systems requirements development and artifacts completion often as a project technical authority. Uses advanced business analysis principles, concepts, methods, standards, and practices to develop business requirements and implement business processes leveraging a broad range of enterprise information technologies aimed at connecting data, workflow, and analytics.
Schedules, participates, and leads Requirements Review meetings. Identifies and clarifies requirements for other functional groups providing expert recommendations for establishing approach, goals, and methods that may include untried methods, incorporation of emerging changes to health science testing methods, or emerging best practices. Elicits requirements from project stakeholders serving as an expert resource providing options and alternatives for defining requirements and applying established and emerging technology and methods. Works closely with the various customers and the internal development teams to embrace change that can be suggested to the customer as well as validate requirements were met serving as an expert resource for addressing emerging and ongoing issues and problems providing options for incorporating new practices and techniques.
How to Apply
Submit resume or curriculum vitae, transcripts with cover letter, in one (1) combined PDF document, by January 17, 2024, to CDRHRecruitment@fda.hhs.gov. Candidate resumes may be shared with hiring official within the CDRH with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”. Please include the following Job Reference ID in the subject line of your email submission: CDRH/OST IT Program Manager PBM-3960
PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply to this announcement. Officers must follow the instructions for how to apply and include their most recent orders in addition to the required documents. If selected, candidates will be referred to (CC) personnel and not as candidates for a Cures appointment.
Announcement Contact
For questions regarding this Cures position, please contact Mariela Mercedes at mariela.mercedes@fda.hhs.gov
The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer.