Silver Spring, Maryland
Department of Health and Human Services (HHS)
Food and Drug Administration (FDA)
Center for Devices and Radiological Health (CDRH)
Office of Strategic Partnerships and Innovation (OST)
Division of Digital Health (DDH)
Position(s): Division Director
Series: The position may be filled by candidates from the following occupational series: General Engineer (0801), Computer Engineer (0854), Mathematics (1520), Mathematical Statistician (1529), Statistician (1530), Data Science (1560), and Computer Science (1550)
Location(s): Silver Spring, Maryland, FDA headquarters, White Oak Campus
Travel Requirements: This position may require up to 25% travel.
Application Period: Wednesday, August 31,2022, through Tuesday, September 20, 2022
Salary: Salary starts at $168,914.00 and is commensurate with education and experience
Conditions of Employment: U.S. Citizenship or permanent U.S. residency is required
Special Notes: This position is being filled under an excepted 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 the authority. Additional information on 21st Century Cures Act can be found here.
Introduction: The Center for Devices and Radiological Health (CDRH or Center) assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. The Office of Strategic Partnerships and Technology Innovation (OST or Office) provides leadership for all scientific, collaborative, and emerging technology activities for the Center. OST represents CDRH and collaborates with a broad and diverse array of national and international entities, with mutual interests in medical devices, combination products, and radiation-emitting diagnostic equipment, including other government agencies, Congress, industry, academia, consumer and patient organizations, and healthcare professional organizations.
The Division of Digital Health (DDH or Division) works to address cross cutting digital health issues across the Center. This Division shares its digital health technical expertise across aspects of a Total Product Life Cycle (TPLC) paradigm to support innovation, while promoting a unified and consistent approach in the evaluation of digital health medical devices. The Digital Health Center of Excellence (DHCoE), housed with the Division, is charged with empowering stakeholders, developing novel, safe, and evidenced-based approaches to regulating these technologies, as well as influencing policy and standards to advance healthcare delivery and improve patient outcomes by fostering responsible and high-quality digital health innovation.
Position Summary: The Center is seeking an experienced and collaborative leader committed to medical device innovation, public health, and improving the health outcomes of patients to serve as the Director of the Division of Digital Health and lead CDRH’s DHCoE. In these positions, you will work to establish new regulatory pathways for the evaluation of novel digital health technologies and serve as the Center’s authoritative voice on matters related to digital health including, but not limited to health information technology, medical device software, mobile medical device applications, interoperability, and cybersecurity. Further, you will reinforce the Center’s global presence and commitment to advancing medical device innovation by participating in international harmonization efforts through the International Medical Device Regulators Forum (IMDRF) and by serving as a liaison to industry, scientific professional associations, patient advocacy organizations, academia, the healthcare provider community, and other government entities and regulatory bodies, domestic and foreign.
Supervisory Responsibilities: You will manage and grow high-performing, multidisciplinary scientific, technical, and professional teams in support of advancing the strategic vision of the Office. As such, you will monitor and evaluate the technical performance of Division staff who serve as experts in their respective fields. You will also devote at least 25 percent of your time towards coaching, mentoring, and supervising your employees.
Duties/Responsibilities: As the Division Director and leader of the DHCoE, you will:
- As a recognized national expert in the area of digital health technologies, you will serve as an authoritative and principal advisor to the OST Office Director and Center leadership on matters involving digital health medical devices, medical device software, and emerging technologies.
- Lead the Center’s DHCoE initiative and in collaboration with CDRH executive leadership develop, define, and implement the Center’s digital health strategy, to include building capacity to evaluate third-party certifiers of digital technologies through the creation of a new pre-certification model and program, with a dedicated cybersecurity unit.
- Serve as the FDA’s Digital Health Advisory Board Chair and lead the coordination of digital health efforts across the Agency, identify research, policy, and engagement priorities, and forge strategic public and private partnerships with patient and provider communities, as well as industry to advance scientific input, modernize regulatory approaches, and protect patients, while building capacity, growing the industry, and facilitating innovation.
- As the Center’s expert regarding digital health medical device technology, you will share information and provide consultation to the Department and FDA officials, other federal agencies, the medical device industry, the healthcare community, national and international standard organizations, professional scientific associations and societies, and patient advocacy organizations on new policies, regulations, effectiveness, reliability, security, and patient safety data regarding these products.
- Ensure the support of product advisory panels, industry, and consultants and coordinate 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
- Prepare and draft Office, Center, and Agency recommendations and responses to official inquiries, most of which will be technical in nature and/or policy focused, to describe regulatory science activities, analysis, results, and conclusions to assist in supporting and advancing digital health medical device regulation.
- Ensure the uniformed high quality and consistency of scientific, technical, and clinical reviews encompassing the total product life cycle of digital health medical devices across the Center.
- Engage and collaborate with patient advocacy groups, industry, healthcare, and scientific communities to address all adverse event data and medical concerns associated with digital health medical devices and software.
- Represent the 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 digital health medical device regulatory activities, plans, policies, and decisions.
- Advise Office and Center leadership on the utilization of new and emerging technologies associated with artificial intelligence, machine learning, and software in the analysis of digital health medical device data to detect early signals, trends, and other critical information.
Professional Experience/Key Requirements: To qualify for this position, you must demonstrate in your resume the necessary qualifying experience, which includes the following:
- Managing and leading diverse multidisciplinary staff in large and complex organizations responsible for the scientific, technical, public health, and regulatory activities associated with FDA regulated products.
- Evidence of leading strategic achievement of organizational goals, evaluating workforce performance, and deploying effective interventions to improve organizational outcomes.
- Developing policies, protocols, guidance documents, and/or recommendations which speak to the safety, efficacy, precision, and reliability of medical products.
- Ability to analyze and interpret regulatory policy and guidance to share expertise and advise leadership on highly complex and precedent setting public health matters.
- Have wide-ranging technical expertise in medical device infrastructure development and implementation, business analytics, artificial intelligence, machine learning, and modeling.
- Ability to effectively communicate through memoranda, position papers, and presentations to executive leaders and other clinical, engineering, technical, and scientific experts.
Desirable Qualifications and Experience:
- Applicants with degrees in Computer Science, Computer Engineering, Cybersecurity, Data Science, Engineering, Mathematics, or related fields.
- 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.
Candidates must meet the educational and individual occupational requirements to qualify for the appropriate series applicable to the position. Please use the following link to determine the series for which you qualify: https://www.opm.gov/policy-data-oversight/classification-qualifications/general-schedule-qualification-standards/#url=List-by-Occupational-Series
Conditions of Employment:
- A probationary period may be required.
- Background and/or Security investigation required.
- All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption.
- This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. For additional information on the prohibited financial interests, visit the FDA Ethics and Integrity Office website at https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.
How to Apply: Submit an electronic resume or curriculum vitae, cover letter containing a brief summary of scientific accomplishments, SF-50 (if applicable), and a copy of unofficial transcripts all in one document (Adobe PDF) to CDRHRecruitment@fda.hhs.gov, with Job Reference code “2022-OST-DDH-DHCoE” in the subject line. Applications will be accepted through September 30, 2022.
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
Federal agencies must provide reasonable accommodation to applicants with disabilities where appropriate. Applicants requiring reasonable accommodation for any part of the application process should follow the instructions in the job opportunity announcement. For any part of the remaining hiring process, applicants should contact the hiring agency directly. Determinations on requests for reasonable accommodation will be made on a case-by-case basis.
A reasonable accommodation is any change to a job, the work environment, or the way things are usually done that enables an individual with a disability to apply for a job, perform job duties or receive equal access to job benefits.
Under the Rehabilitation Act of 1973, federal agencies must provide reasonable accommodations when:
- An applicant with a disability needs an accommodation to have an equal opportunity to apply for a job.
- An employee with a disability needs an accommodation to perform the essential job duties or to gain access to the workplace.
- An employee with a disability needs an accommodation to receive equal access to benefits, such as details, training, and office-sponsored events.
You can request a reasonable accommodation at any time during the application or hiring process or while on the job. Requests are considered on a case-by-case basis.
Learn more about disability employment and reasonable accommodations or how to contact an agency.
The Department of Health and Human Services is an equal opportunity employer with a smoke free environment.
FDA is an equal opportunity employer
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