With over 30 years of industry experience, Jan Michener Whipple is a Partner at ELIQUENT Life Sciences, specializing in Medical Devices, Invitro-Diagnostics and Combination Products. Based in Southern California, Jan has a comprehensive background in global Quality, Regulatory Compliance, and Management Consulting for the full product lifecycle including Product Design, Risk Management, Supply Chain Operations, Post-Market Surveillance, Audits and Inspections, as well as enforcement response and remediation. Jan works to stay at the forefront of global regulatory intelligence and industry best practices to provide client solutions at both the strategic and execution levels.

Jan has been a part of ELIQUENT Life Sciences since 2013 and has worked both as a hands-on consultant and as an advisor. Jan’s responsibilities have included serving as interim Head of Quality, leading acquisition integrations, facility start-up, technical transfers and plant closures, preparation for agency inspections and Notified Body audits, Warning Letter remediation, quality management system design, new product introductions, customer complaint and post-market surveillance remediation, and implementation of new/revised global regulations and standards including ISO 14971:2019, ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), 21 CFR Part 4 Regulation of Combination Products, the European Union Medical Device and Invitro-Diagnostic Regulations (EU MDR and IVDR), the revised 21 CFR 820 US FDA Quality Management System Regulation (QSMR) and others. Within ELIQUENT Life Sciences, Jan develops unique client solutions, provides project oversight of consulting teams, and delivers advisory and implementation consulting services.

Jan has held management positions in Quality Assurance, Quality Control, Quality Systems and Compliance, Manufacturing Engineering, Packaging & Cold Chain Process Development, Supplier Management, Warehousing & Distribution, and has served as the Management Representative. In addition to a Bachelor of Science degree in Mechanical Engineering, a Master’s degree in Business Administration, and completion of several post-graduate and certification programs, Jan maintains an active Professional Mechanical Engineering License in the state of California. To stay current with industry trends, best practices, and evolving regulatory requirements, Jan is actively involved in industry technical and trade associations, serving on the Board of Directors, engaging as a public speaker and author of quality and regulatory content, participating in the membership, and leading local network discussion groups.