The Medical Device Innovation Consortium (MDIC) is the first-ever 501(c)3 public-private partnership created with the sole objective of advancing medical device regulatory science for patient benefit. As a membership-based organization, MDIC brings together representatives of the Food and Drug Administration (FDA), National Institutes of Health (NIH), Centers for Medicare & Medicaid Services (CMS), industry, non-profits, and patient organizations to improve the processes for development, assessment, and review of new medical technologies. Our work is unique and complementary to trade associations such as the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA). Members of MDIC share a vision of providing U.S. patients with timely access to high-quality, safe, and effective medical devices.
In September 2016, the FDA awarded a grant for the National Evaluation System for health Technology Coordinating Center (NESTcc) to MDIC. The mission of NESTcc is to accelerate the development and translation of new and safe health technologies, leveraging Real-World Evidence (RWE) and innovative research. Stakeholders across the medical device ecosystem stand to benefit from improved use of RWE generated in the routine course of care. Beginning in 2018, the FDA awarded supplemental funding for NESTcc to develop active surveillance capabilities.
Under the direction of the NESTcc Data Network Director, the consultant will provide expert input into the development of NESTcc’s medical device safety surveillance capabilities and help identify the regulatory, legal, and data requirements that will support such a capability. This position is temporary and will end on December 31, 2019, with an opportunity to extend. He/she will work closely with the NESTcc Active Surveillance Task Force, which launched in January 2019 and is developing a preliminary roadmap for the direction of NESTcc active surveillance activities. NESTcc’s active surveillance system will be developed to utilize the NESTcc Data Network to address safety signal refinement and to detect safety signals. The active surveillance capabilities will be designed to support FDA initiated active surveillance questions and active surveillance questions submitted from other stakeholders.
Objectives and Responsibilities
NOTE: This scope of services is not intended to be all-inclusive. Individual may be asked to perform other related duties as required to meet the ongoing needs of the organization.
To apply, please submit a resume, salary requirements and cover letter by email to: careers at mdic.org
Job Type: Temporary