Lori Kahler – Consultant, Quality/Regulatory Systems

Lori Kahler is a highly accomplished professional with over 30 years domestic and international experience in the management of operations, quality, regulatory, and compliance, with proficiency across a full range of business functions and systems, including strategic development and planning, budgeting, business analysis, finance, and information systems.  Lori has successfully directed strategic programs in support of business goals to effectively gain market entry globally, advance product performance, and improve healthcare outcomes.

As the founder and managing director of The RC Insight Group, Lori has a unique blend of experience in competitive intelligence gathering, strategic management, and regulatory and clinical strategy development.  She ensures competent evaluation and implementation of product market pathways that are both compliant and cost effective for domestic and international based customers, while successfully navigating the complex and highly evolving life sciences landscape.  Lori has advised and directed clients’ projects from pre-market strategy through product concept and development to final post-market/ pharmacovigilance activities.

Positions Lori has held include VP of Global Operations/ QARA, INVO Bioscience Inc.; VP of Regulatory Affairs, Oriel SAM; Director/ Authorized Officer (AO), Samsung Electronics America, Inc.; VP Regulatory and Clinical Operations, Ximedica, LLC; and Global Director of Quality Operations & Regulatory Affairs Cardiovascular IT/ Managing Director, Asia-Pacific Region, Agfa-Gevaert NV. Her portfolio of clients includes the following:  Anika Therapeutics Inc., Combe, Cynosure, Pfizer Consumer Healthcare, Johnson & Johnson, King Pharmaceuticals, Koven Technology Inc., Smith & Nephew, Smiths Medical Inc, and Ulrich Medical USA, Inc.

Always Keep Improving!