Swapna Khopkar

Swapna Khopkar is a seasoned regulatory affairs professional with extensive experience in the medical device and pharmaceutical industries. Currently serving as a Sr. Regulatory Affairs Specialist at Yukon Medical, LLC since February 2024, Swapna has shown expertise in supporting MDR 2017/745 compliance, leading significant eSTAR 510(k) submissions, and authoring clinical evaluation reports. Previous roles include senior positions at Teleflex and Yukon Medical, where Swapna managed international regulatory submissions and device registration for multiple countries. Swapna's career began in regulatory affairs and quality assurance with companies like Gufic Stridden Biopharma Pvt. Ltd. and SKS Laboratories Ltd. Educational qualifications include a Bachelor of Pharmacy from Rajiv Gandhi University of Health Sciences and a Regulatory Affairs Certificate from the Regulatory Affairs Professionals Society.