Janine Morris's Email Addresses & Phone Numbers

💼 Past Experience

Summary of Janine Morris's experience: Janine Morris is currently a Vice President | Senior Research Fellow at Eli Lilly and Company in Cambridge, MA. Provide regulatory leadership and support for Connected Care projects at the Eli Lilly Innovation Center Cambridge, MA site. Will partner with scientists and engineers across the organization to enable the Connected Care vision and engage in other projects as they develop at the Cambridge site. Deputy Director for Policy, Regulatory Science and Strategic Collaboration at FDA | Office of the Commissioner | Office of Special Medical Programs from January 2015 to December 2016 (2 years) in Silver Spring, MD. Deputy Director for Policy, Regulatory Science, and Strategic Collaboration for the Associate Commissioner in the Office of Special Medical Programs (OSMP). OSMP serves as the agency focal point for special programs and initiatives that are cross-cutting and clinical, scientific, and/or regulatory in nature. OSMP provides oversight and executive leadership to the Office of Combination Products, Office of Good Clinical Practice, Office of Pediatric Therapeutics, Office of Orphan Products Development, and the Advisory Committee Oversight Management Staff. Division Director at FDA | Office of the Commissioner | Office of Special Medical Programs from February 2012 to July 2015 (3 years 6 months) in Silver Spring, MD. Director of the Division of Radiological Health where the FDA regulates the safe and effective use ofradiological medical devices and the safe use of all radiation emitting products. Deputy Director for Policy, Regulatory Science, and Strategic Collaboration for FDA | Office of the Commissioner | Office of Special Medical Programs from May 2001 to December 2007 (6 years 8 months). Senior Scientific Reviewer at FDA | Office of the Commissioner | Office of Special Medical Programs from July 1990 to May 2001 (10 years 11 months). Senior Scientific reviewer in premarket review of medical devices. I have over 10 years experience in 2 of the largest divisions in the Office of Device Evaluation: Division of Cardiovascular and Division of General, Restorative, and Neurological Devices. Expertise includes reviews of all submission types for neurology, cardiovascular, orthopedics, neurovascular, breast implants, etc. Branch Chief at FDA | Office of the Commissioner | Office of Special Medical Programs from August 2010 to January 2012 (1 year 6 months) in Silver Spring, MD. Branch chief in the premarket review of urology and lithotripsy devices in the Office of Device Evaluation in Center for Devices and Radiological Health. Managed 12 employees in the premarket review of urology and lithotripsy devices. Held a leadership role in ongoing cross-cutting issues both technical and management based including Staff College course development, outside leveraging activities, antimicrobial device policy issues, combination products, biocompatibility, biomaterials and surface modifications, etc. Chair for Quality Review Program for Biocompatibility of Medical Devices. Participant and Division Lead on Center working group to reduce hospital acquired infections associated with reprocessed medical devices. Panel representative for ODE at the FDA Medical Devices Technology Innovation (MD TIP) partnership. Acting Division Director for Division of Reproductive, Abdominal, and Radiological Devices at FDA | Office of the Commissioner | Office of

🎓 Education

Janine Morris's education provides insight into her work readiness. She has a degree from Liscentiate, Engineering at Luleå University of Technology, where she learned about engineering solutions forday-to-day problems and the process of creating them. Janine then obtained her BSME from the University of Maryland, where she studied mechanical engineering. This background allows her to be excited about working with things that have consequences and can exist in a variety of different environments. She is currently a Mechanical Engineer at the company her husband founded in early 2018.

💡 Technical & Interpersonal Skills

Janine Morris has experience in Regulatory Science and Strategic Collaboration at the FDA. As a Deputy Director for Policy, Regulatory Science, and Strategic Collaboration at the FDA, Janine Morris held a leadership role over 57 professional and multidisciplinary staff tocarryout the mission of the Center to promote and protect the Public Health regulatingradiological medical devices and other radiation emitting electronic products. She also has experience in Network Leader for Cardiothoracic and Peripheral Vascular Devices (CPVD) Network at FDA, Deskilling at FDA, andSenior Scientific Reviewer at FDA. In her previous role as Branch Chief, Urology and Lithotripsy Devices Branch at FDA, Janine Morris managed a multidisciplined group of clinicians, scientists, and engineers in the premarket review of urology and lithotripsy devices. She also acted as a Senior Scientific Reviewer at FDA for the premarket review of medical devices and is an Expertise in reviews of all submission types for neurology, cardiovascular, orthopedics, neurovascular, breast implants, etc. Janine Morris is a Senior Scientific Reviewer at FDA and a Participant and Division Lead on Center working group to reduce hospital acquired infections associated with reprocessed medical devices. Janine Morris also is Acting Division Director for Division of Reproductive, Abdominal, and Radiological Devices at FDA.