General Manager, FDA Regulatory Affairs and Medical Product Development, and Start Up Company and Alliance Development, Brock Family Center for Applied Innovation (BFCAI)

Discover Vanderbilt University Medical Center:  Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt’s mission is to advance health and wellness through preeminent programs in patient care, education, and research.

Organization:

Office of Research

Job Summary:

JOB SUMMARY
The General Manager for FDA Regulatory Affairs, Medical Product Development, and Start Up Company and Alliance Development in the Brock Family Center for Applied Innovation (BFCAI) will play a pivotal role in advancing innovation and enhancing the reputation of the Vanderbilt University Medical Center BFCAI through knowledge and application of FDA regulatory affairs and the development and implementation of strategies to advance and increase the value of new medical products. In addition, the General Manager will work as an integral part of the BFCAI team to advance internal start-up companies and support the development of corporate alliances. This includes start-up companies and alliances for both life sciences and digital health. The position reports to the Director for the BFCAI. All functions will also frequently involve work in collaboration with the Center for Technology Transfer and Commercialization (CTTC). FDA regulatory affairs work will include support for the IRB on a regular basis for FDA regulatory analysis and recommendations for novel medical device protocols.

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KEY RESPONSIBILITIES

Advises, develops, and leads implementation of strategies for investigators and the institution about FDA regulatory affairs and medical product development

Monitors and analyzes new legislation, federal regulations, guidance documents, standards, and program initiatives; responsible for identifying, interpreting, and applying relevant documentation. Serves as a central resource for the Vanderbilt research community to provide expertise and FDA regulatory and medical product development guidance to facilitate research and commercialization. Demonstrates the ability to understand the science of medical product research and development to actively support institutional activities for FDA-regulated product research. Establishes and maintains communications with investigators and research staff conducting FDA-regulated research, authors and disseminates materials as necessary, and provides training for research personnel as needed. Assists and supports investigators in determining appropriate internal documentation for institutional review board (IRB) human research protection program (HRPP) submission and external documentation (premarket regulatory requirements, including pre-submission documents and request for risk determinations) for FDA submissions. Submit pre-IDE, IDE and risk determination applications to FDA as needed Supports the IRB HRPP and provides written analysis of the risk determination for medical devices and other medical products under review. Assists and supports researchers in the development and management of standard operating procedures and other documentation according to applicable regulations. Actively participates in or leads individual/or institutional FDA regulatory affairs and medical product development projects related to the Brock Center and CTTC. Collaborates with customers across Vanderbilt to develop departmental, team, and individual goals through ongoing training and supplemental support. Participates in development of value in Brock Center and CTTC start-up companies in formation through FDA regulatory strategy and medical product development implementation

Plans, advises, and leads the development of select Start-up Companies and Strategic Alliances for Research and Development in cooperation with the Director of the BFCAI:

1. Start Up Companies: plan, advise, and lead on medical product development in cooperation with start-up company teams particularly for medical products that require FDA regulatory clearance. Strategic Alliance Development: Identify, initiate, and sustain strategic alliances with life sciences and digital health companies to advance the medical center's research and development reputation in cooperation with the BFCAI and Vanderbilt Medical Center Development.

2. Relationship Management: Cultivate and maintain strong relati