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:

21st Century Cures Act Information

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 or Center) 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 the Center Director (OCD) provides vision, leadership, strategic direction for the Center regarding the regulation of medical devices and radiation-emitting products. Also provides leadership and direction for Center-level management, planning, and evaluation systems to ensure optimal utilization of personnel, budgetary and financial resources.

Duties/Responsibilities

The OCD’s Quality Management Staff is responsible for:

• Providing vison, leadership, and strategic direction for the Center regarding quality management, and organizational excellence.
• Establishing and developing resources to facilitate implementation of quality management and organizational excellence for CDRH.
• Integrating applicable quality management and organizational excellence principles and best practices into key business processes.
• Establishing a foundation for quality, effectiveness, efficiency, and improvement for all products, services, and business processes.
• Supporting CDRH's mission to achieve organizational excellence, efficiency and effectiveness while delivering continually improved products and services to provide the public access to safe, effective, and high-quality medical devices and safe radiation-emitting products.

The Operations Research Analyst plans, oversees, and uses process improvement and organizational excellence methodologies to evaluate and improve the Center’s implementation of scientific, legal, policy, regulatory, compliance, communication, and administrative programs, projects, policies, and initiatives. Provides subject-matter expert direction to Center staff and leadership to ensure that regulatory, technical, and operational processes and procedures support effective, efficient, and optimal utilization of personnel, budgetary and financial resources, information technology, and facilities.

The incumbent leads studies, analyses programs, and provides expert quality, process improvement and organizational excellence support to facilitate and coordinate the development, clearance and delivery of strategies, processes, and procedures necessary for the implementation of Congressional mandates and strategic initiatives, including development of plans, strategies, materials, and background information for meetings and projects.

The incumbent is a recognized improvement expert in medical device technical, regulatory, and administrative processes and procedures, providing information, expert advice, and consultation to FDA centers, the Agency, and private industry on the improvement and implementation of processes and procedures to support addressing unique and complex technical, regulatory, and operational medical device program and process issues. The Operations Research Analyst is also an expert consultant in the planning, monitoring, and administration of CDRH quality management and operational excellence programmatic areas including, for example, the Process Improvement Program, the Audit Program, the CDRH ISO 9001:2015 Certified Quality Management System, and a broad range of projects with significant impact on Center strategic priorities.

The incumbent serves as senior analyst as part of a team on the application of quality management and organizational excellence methodologies to technical and regulatory processes, an area with an important impact on the efficiency and effectiveness of CDRH’s regulatory mandates and strategic priorities as well as the agency’s long-term goals. S/he works with the Associate Director Quality Management, the Assistant Director for Process Improvement, Assistant Director the Quality and the CDRH Data Steward and other agency senior leaders to help develop or develop the process improvement and organizational excellence strategies to support implementation of quality management and organizational excellence across the Center. S/he coordinates with CDRH Offices to determine if actions are needed and, if so, identify an approach, collaborates with engineers and medical and healthcare professionals on a wide range of regulatory and policy processes improvement projects as well as consults with Offices/Divisions to identify and resolve quality and organizational challenges affecting CDRH products and services. S/he assists in developing new concepts and procedures, and in ensuring consistency within CDRH. S/he conducts or participates in discussions with stakeholders including scientists, engineers, medical and healthcare professionals, and management officials regarding the impact of quality management and organizational excellence on regulatory policies and procedures. S/he communicate CDRH’s initiatives and goals intelligently and accurately, knowing the importance and implications of people and institutions having differing interests and responsibilities. S/he maintains effective working relationships with medical device experts, works closely with officials and technical specialists on areas such as Medical Device User Fee Acts and associated efforts that directly impact the resources available to the Center to perform its mission. S/he facilitate the development and evaluation of positions and proposals for the solution of complex issues related to quality management, organizational excellence, and process improvement as it applies to medical device regulation; provides authoritative and direct assistance to Center staff and maintains good working relationships while working out substantive disagreements.

The incumbent develops recommendations and provides advice and consultations regarding quality, organizational excellence, and process improvement issues to the CDRH leadership and other key agency officials. Deviates from or extends traditional practices and programs and develops solutions to extremely complex scientific regulatory and technical problems using improvement methodologies. Interprets and applies existing practices, setting precedents that affect CDRH program activities and the marketing of regulated medical device products. Uses quality and process improvement methodologies to improve the development and application of processes associated with policies, procedures, guidance, and regulations for medical device products and works with senior and expert subject matters across the FDA and CDRH as appropriate.

The incumbent provides expertise on quality management and process improvement to FDA’s technical experts and is responsible for leading others in Center Strategic Initiatives applying quality management and process improvement to all activities that further the Center’s mission. In addition, s/he engages in strategic planning on resource issues related to all of the above-mentioned activities (e.g., identifies innovative sources of manpower and dollars to support Center initiatives). Participates directly in the planning and execution of implementation and improvement activities relevant to the oversight of regulatory activities, including agreements in the Medical Device User Fee Act.

The incumbent is a subject-matter expert and works closely with the Center leadership to develop, evaluate, and gain Center consensus on quality and process improvement projects that directly impact policies, concepts, strategies, negotiating positions, procedures, and other courses of action. Through persuasion and leadership, ensures consistency across the Center in both the development and implementation practices and process supporting implementation of new policies. S/he provides guidance to professionals located in other parts of the Center who are developing and carrying out quality management and process improvement activities and represents the center on task forces, planning groups, or special study groups.

How to Apply

How to Apply: Submit resume or curriculum vitae, cover letter by July 12, 2024, CDRHRecruitment@fda.hhs.gov. Compile all applicant documents into one combined document (i.e., Adobe PDF). 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/OCD/Operations Research Analyst -C

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.