Adhithya Arumugasamy

Regulatory Affairs Specialist at Carl Zeiss India Private Limited (September 2020 to Present) Senior Regulatory Affairs Associate at Randstad Pvt Ltd (Deputed to Carl Zeiss India Pvt Ltd) January 2020 to August 2020 Role: Regulatory Affairs – Medical Devices Products: Software as Medical Devices (SaMD) – Class I & IIa Responsibilities: • Responsible for authoring, review and submission of Regulatory documents like Technical File / STED, General Safety & Performance Checklist etc.,

Senior Executive - Regulatory Affairs Biocon Biologics India Private Limited | Bengaluru, India Role: Regulatory Affairs – Medical Devices Products: Reusable Injectors, Disposable Injectors • Responsible for planning and execution of device regulatory submissions and all other regulatory related activities, globally for Reusable Injectors & Disposable Injectors(Combination Products) • Responsible for authoring, review and submission of device related sections of different combination products

Role: QMS, Engineering Compliance activities, Design change Control, Regulatory Submissions, Document Control. Electrical Safety Testing for new product developments Products: Image Guided Navigational Needle Positioning Systems (Robotic Device works with CT)

Maintaining and Execution as per Quality Management System ISO 13485 for Medical Devices • Working on Observing Significant Changes in Medical Devices and Notify to Regulatory Bodies like FDA, CE, CFDA, PMDA for Regulatory Submissions •• Document Control

Bachelor of Engineering (BE) | Electrical and Electronics Engineering Anna University, Chennai, TN Bachelor of Engineering (BE), Electrical and Electronics Engineering, 2011 – 2015, passed out with First class, 7.5 GPA