Travel Requirements: This position may require up to 25% travel.
Application Period: Monday, August 16, 2021, through Tuesday, September 21, 2021
Salary: Salary is commensurate with education and experience (see below)
Conditions of Employment: U.S. Citizenship or permanent U.S. residency is required
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. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
Within CDRH, the Office of Strategic Partnerships and Technology Innovation (OST or Office) provides leadership for all scientific, collaborative, and emerging technology related activities at the Center. OST represents the Center and collaborates 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.
Shortages in medical devices can present a substantial threat to the nation’s public health infrastructure. Specifically, interruptions in medical device supply chains can obstruct and prevent the provision of lifesaving and life-sustaining care to patients. As such, OST has established a Resilient Supply Chain and Shortages Prevention Program (RSCSPP or Program). This Program will develop innovative and effective national strategies, in collaboration with industry, as well as public and private stakeholders, to ensure adequate inventories of safe, effective, and reliable, medical devices and products are available and accessible for patients who need them.
Position Summary: CDRH is seeking a creative, public health-minded, and experienced Health Scientist to support the Center’s efforts in protecting and preserving the nation’s medical device supply chain. Reporting to the RSCSPP Director, you will serve as an expert programmatic advisor to the Director and will be responsible for developing, coordinating, and advancing activities to support the Center’s medical device supply chain activities. If selected, you will collaboratively, with other leaders across the Center and Agency develop, present, and institute medical device shortage mitigation strategies and tactics to address both noted and hidden vulnerabilities in the nation’s medical device supply chain. Additionally, with the use of analytics, trends, and modeling, you will evaluate current supply chain systems, safeguards, and methodologies to address all existing and/or conceivable weaknesses and risks factors.
Duties/Responsibilities: As a Health Scientist in this space you will:
As a scientific and regulatory leaders, as well as a resident expert on medical device supply chain and logistics management, you will serves as a cogent voice in the provision of sound, theoretical, and evidence-based information to ensure the sustained availability of medical devices during public health emergencies, both natural and man-made.
Utilize expert supply chain and logistics knowledge, risk mitigation expertise, and scientific and regulatory experience to collaboratively advance the RSCSPP’s medical device supply chain program and serve as an expert on the Center’s cross-functional supply chain team.
Cultivate formal and informal partnerships with medical device manufacturers, suppliers, carriers, scientific associations, organizations, and societies, patient-focused, foreign stakeholders, to include international producers and government entities, and other U.S. government officials at the federal, state, and local levels regarding supply chain concerns and regulatory impact of disruptions.
Collaborate with colleagues to continuously evaluate the performance and impact of the Center’s supply chain program and research new and emerging technologies to enhance data collection, analysis, storage, transference, and programmatic to advance the goals and objectives of the Resilient Supply Chain Program.
Collaborate with Agency colleagues to share and leverage medical device supply chain resources, knowledge, benchmarks, and best practices.
Evaluate the causation of various supply chain shocks, through data analytics, and develop and share mitigation strategies across the Office and Center, as well as with industry, suppliers, contract manufacturers, distributors, and other stakeholders to stem potential disruptions within the medical device ecosystem.
Draft recommendations to address supply chain vulnerabilities and risks, which could lead to potential disruptions.
Serves as an authoritative voice regarding the regulation of medical devices and radiation emitting diagnostic equipment.
Develops research projects to supports o address knowledge deficits and to support regulatory decision-making.
Conduct analyses of existing technologies in comparison with needed capabilities to support medical device supply chain data analytics implementation.
Share recommendations on cloud-based solutions and customized software to support supply chain business technology integration needs.
Utilize your vast scientific and regulatory knowledge to interpret regulations, develop and issue rulemaking, guidance, and other policy and resource documents.
Represents the Program and Office, as well as, lead and chair professional meetings and conferences with Agency partners, other departments, and federal entities, national/international industry representatives and academic, professional, and scientific associations, organizations and societies, patient-centric groups, and state and local public and private partners regarding regulatory concerns impacted by disruptions in the medical device supply chain.
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:
Solution focused public health professional with superior project management and highly effective communication skills who can successfully lead and manage large-scale and long-range initiatives of national significance.
Experience in evaluating, as well as enhancing medical device supply chains across large and complex scientific, health care, and regulatory organizations, to mitigate vulnerabilities and potential disruptions.
Experience in leading and managing change in health care, medical devices, biotech, pharma, or other FDA regulated ecosystems.
Experience as a strategic advisor with the ability to engage, build, and sustain relationships with internal and external stakeholders.
Establishing and integrating complex, cross-organizational process, data governance, and information management strategies, and establishing strategic metrics and milestones centered on supply chain resiliency.
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 environment.
Ability to manage multiple projects and effectively lead and develop employees.
Basic Qualifications: In order to qualify for this position, you must meet the educational requirements outlined in the Office of Personnel Management (OPM) Qualification Standards for the General Health Scientist occupational series listed below. Please access the hyperlink to view the educational requirements to learn if you qualify: General Health Scientist/Epidemiologist (0601)
Position Levels: This position will be filled at the GS – 14, which has a corresponding salary range of $122,530 to $159,286, based on knowledge and experience.
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 “2021-OST-IO-020T-Health Scientist” in the subject line. Applications will be accepted through September 21, 2021.
The Department of Health and Human Services is an equal opportunity employer.