Kari Lahti
Director of Regulatory Affairs @ Medtronic
United States
Minneapolis
Medical Device
FDA, ISO 13485, Quality System, CAPA, Medical Devices
Experience
Director of Regulatory Affairs
Medtronic
Sr. Regulatory Affairs Manager
Medtronic
Fridley, Minnesota, United States
Lead a regulatory team supporting pre- and post-market activities for Pelvic Health OU US FDA submissions - Pre-Submission, IDE, PMA (including Original), 510(k) SaMD
Sr. Principal Regulatory Affairs Specialist
Medtronic Cardiac Ablation Solutions
Led teams supporting pre- and post-market activities for Cardiac Ablation Solutions US FDA Submissions – Pre-Submission, IDE, PMA (including Original, Panel-Track), 510(k) EU MDR, MDD, UKCA International registration Regulatory and Clinical Program Management Regulatory Integration for multiple acquisitions
Principal Regulatory Affairs Specialist
Medtronic Atrial Fibrillation Solutions
Regulatory Affairs Program Manager
Medtronic AF Solutions
Business Integration and Planning Manager
Medtronic
Product Development Manager
Medtronic CRM
Education
University of Minnesota
Chemical Engineering
University of Minnesota
Marketing; Finance
Kari Lahti's Contact Information
Phone
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