Tim Kappers

Tim Kappers has extensive experience in the medical device industry, with a focus on quality, regulatory affairs, and clinical operations. Tim currently holds the position of Senior Vice President of Quality, Regulatory and Clinical Affairs at Crossfire Medical. Prior to this, Tim served as the President of Device Strategies, Inc. from 2013 to 2022.

Before joining Crossfire Medical, Tim worked at Cardiovascular Systems, Inc. as Vice President of Quality & Regulatory Affairs. In this role, they established strategic global direction and processes for quality and regulatory operations, leading a team of 60 employees with a $15.5M budget. Tim held this position from 2017 to 2022.

From 2009 to 2012, Tim was the Senior Manager of Regulatory Affairs at St Jude Medical. Tim provided strategic direction and planning for the Atrial Fibrillation Division, overseeing a team of up to 45 employees with a $7.4M budget.

Prior to their time at St Jude Medical, Tim held the position of Vice President of Quality, Regulatory and Clinical Affairs at Orasi Medical, Inc. In this role, they led the establishment of strategic direction, planning, and processes for quality, regulatory, and clinical affairs for the medical device software company. Tim also played a key role in FDA pre-IDE meetings and created a new ISO 13485 compliant quality system. Tim held this position from 2008 to 2009.

Tim's earlier experience includes serving as the Director of Regulatory & Clinical Affairs at Vital Images, Inc. from 2003 to 2008. In this role, they directed a team of 30 employees in regulatory affairs, clinical operations, quality, and technical writing. Tim implemented a novel regulatory submission strategy and played a crucial role in obtaining international approvals, contributing to a revenue growth of 350%.

Overall, Tim Kappers has demonstrated expertise and leadership in quality, regulatory affairs, and clinical operations throughout their career in the medical device industry.

Tim Kappers has an Executive MBA degree from the University of Minnesota - Carlson School of Management. Tim also holds a degree in Genetics & Cell Biology from the University of Minnesota. However, no specific start or end years are provided for either of their educational experiences.