Position Summary: CDRH is seeking an experienced and innovative scientific, technical, and regulatory expert to serve as Deputy Division Director of DIDSR. In this position, reporting directly to the DIDSR Director, you will have the opportunity to universally impact and improve the health outcomes and the quality of life of the American people through the advancement of diagnostic imaging medical devices. You will be responsible for providing leadership, administrative management, and exercising sound scientific and evidenced-based technical judgement in the review of in-scope medical products throughout their total product lifecycle. Your critical regulatory work and the utilization of your vast scientific and technical expertise will assist the Director in advancing the mission of the Division, Office, and Center.
You will assist the DIDSR Director in setting strategy, advancing initiatives, and ensuring the goals, priorities, and objectives of the Division align with those of OSEL, the Center, and Agency. As a creative and collaborative leader, you will assist in managing and growing a high-performing, multidisciplinary scientific, technical, and professional team, for optimal efficiency and performance, in support of advancing the strategic vision of the Office. As such, you will evaluate the technical and managerial performance of your subordinate supervisors and devote at least 25 percent of your time towards coaching, mentoring, and supervising your leadership team.
As the DIDSR Deputy Division Director, you will:
· Utilize expert scientific and technical knowledge and vast regulatory expertise to serve as an authoritative and principal advisor to the DIDSR Director, as well as the OSEL Office Director, on matters involving diagnostic imaging medical devices, both novel and existing, encompassing the entire product lifecycle.
· Collaborate with colleagues across the Division and Office to develop new guidance documents, policies, and national and international consensus standards regarding the regulatory and scientific review of emerging diagnostic imaging and radiation emitting medical devices.
· Ensure the uniform adoption, implementation, and consistent application of OSEL guidance, procedures, and policies, regarding the regulatory oversight of medical products within the scope of the Office, are followed.
· In concert with the DIDSR Director and Office Director, develop, coordinate, and establish Division-wide policies, procedures, and programmatic norms rooted in science to assure diagnostic imaging medical products, especially those with novel and emerging technology, are safe, effective, reliable, and available for patients and providers.
· Provide technical advice, scientific leadership, and expert guidance in the review of policies and procedures associated with the regulated medical device imaging industry, regarding patient safety and product quality.
· Collaborate with the DIDSR Division Director and the OSEL Office Director in the planning, organizing, and the establishment or realignment of priorities, assignments, and work projects to advance new initiatives and/or the programmatic and regulatory objectives of the Division and Office.
· Partner with the Division Director to conduct regulatory science research, participate in pre- and post-market medical device review and surveillance activities, develop domestic and international consensus standards, regulatory guidance, testing of forensic and regulatory samples, and provide training and educational programs in the area of science and engineering.
· Represent the Division, Office, Center, and Agency at meetings, discussions, advisory panels, and conferences involving officials from the Department and other Federal, state, and local government agencies, foreign governments and international agencies, the scientific, academic, and medical communities, and representatives of regulated industry to present and explain DIDSR activities, plans, policies, and decisions.
· Advises the Division Director and Office leadership on the utilization of new and emerging technologies associated with artificial intelligence and machine learning in the analysis of digital health medical device data to detect early signals, trends, and other critical information.
· Draft decisions and recommendations of national public health significance, which may impact the availability of certain products due to safety, efficacy, and reliability concerns.
· Forge mutually beneficial formal partnerships with medical device manufacturers, foreign agencies, professional scientific organizations, health care community, patient advocacy groups, academia, and other federal, state, and local stakeholders.
· Creates and sustains a strong and dynamic culture within the Division including organizational agility, a focus on continuous improvement, and staff empowerment and collaboration.
· Ensures the comprehensive support of product advisory panels, industry, and consultants and coordinates actions on classification actions, petitions, premarket notifications (510(k)s), premarket approval applications (PMAs), PDPs, De Novos, 513(g)s, and Investigational Device Exemptions (IDEs) with Center and Agency components or other organizations, when appropriate.
Professional Experience/Key Requirements:
To qualify for this position, you must demonstrate in your resume the necessary qualifying experience for this position, which includes the following:
· Experience in leading and managing multidisciplinary scientists, clinicians, and other regulatory professionals in large-scale science-based organizations.
· Ability to analyze and interpret regulatory policy and guidance to share expertise and advise leadership on highly complex and precedent setting public health matters.
· Leads the strategic achievement of organizational goals, evaluating organizational performance and taking action to improve performance.
· Ability to build collaborative and mutually beneficial working relationships with a diverse cadre of customers and stakeholders.
· Skillful in effectively interpreting and presenting complex scientific, technical, and regulatory information and concepts, in both written and oral formats, for a variety of audiences.
Desirable Education and Experience:
· Applicants with advanced degrees in engineering, biomedical engineering, physics, computer science, healthcare disciplines, or related field.
· Prior experience in a scientific, regulatory, or medical device manufacturing setting.
· Ability to work collaboratively with a diverse cadre of colleagues and stakeholders in a continuous quality improvement ecosystem.
Conditions of Employment:
· A probationary period may be required.
· Background and/or Security investigation required.
Equal Employment Opportunity Policy
The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.
Reasonable Accommodation Policy
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