Alyce Linthurst Jones
VP, Global Regulatory and Clinical Affairs @LifeNet Health
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WORK HISTORY
VP, Global Regulatory and Clinical Affairs @LifeNet Health
Virginia Beach, VA, US
Provides strategic leadership for regulatory and clinical affairs and possesses expertise while developing new approaches for business objectives. Drives and enhances the operational effectiveness of the Regulatory & Clinical Affairs function, including recommending solutions to reduce system complexities and inefficiencies. Combines knowledge of scientific, regulatory, clinical, medical and business issues to enable products that are developed, manufactured or distributed to meet required regulatory/compliance/legislation. Plans, directs, coordinates and controls the Regulatory and Clinical Affairs activities related to products worldwide. Acts as a Change Agent with the ability to influence at all levels of the organization. Oversees development and implementation of regulatory & clinical strategies and guidance based on U.S. and International Laws and Regulations. Establishes effective dialogue with U.S. and International regulatory authorities. Represents the regulatory aspects of product-associated events, recalls and product withdrawals. Leads efforts to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g, orphan, conditional approval, breakthrough therapy) or for complex and/or critical products. Analyzes and compare regulatory outcomes with initial product concepts and recommends future strategies and actions.
EDUCATION
Old Dominion University
BS, MS, PhD, BS-Biology w/ a minor in chemistry, MS-emphasis in immunology, PhD-emphasis cell biology/tissue eng
SKILLS
ABOUT ALYCE LINTHURST JONES
Over the last twenty-four years I have developed a breadth and depth of scientific, regulatory, clinical and product development knowledge directly applicable to the realization of novel tissue-based products and medical devices. During this time, I have gained significant regulatory experience in bringing novel tissue-based medical devices through the US FDA through numerous on-site presentations at FDA and authoring multiple submissions [HDE, IDE (inclusive of clinical trial), pre-RFD, RFDs, Pre-submissions (clinical and pre-clinical), Innovation Pathway and multiple 510(k)s]. I have also supported regulatory submissions to numerous countries. I have over sixteen years of experience leading cross-functional teams utilizing FDA’s Design Control process and providing thorough technical reviews for a broad range of tissue based grafts (spine, orthopedic, trauma, sports medicine, breast reconstruction and wound). My broad scientific knowledge base, regulatory experience, strategic vision, problem-solving skills, creativity, cross functional facilitation skills, interpersonal skills, leadership of high performing teams and work ethic make me well-suited to lead forward looking Regulatory, Clinical, Research and Product Development groups.
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