Adhithya Arumugasamy
Angestellt, Regulatory Affairs Manager, Siemens Healthineers
Hosur, Indien
Über mich
I am Adhithya, located in Chennai, experienced in Regulatory Strategy and execution, Quality Management and Regulatory Intelligence across diverse medical devices (Class I, Class IIa & IIb) for US, EU and Global markets. Diverse product experience - Medical imaging equipment's, Digital Health (AI/ML based Medical Device) & SaMD's, Combination products, Drug Delivery devices for US, EU, India-sub continent and Global markets. • Proven leadership in developing and executing global regulatory strategic plans for new product development and lifecycle management. • Managed complex regulatory submissions to achieve product registration, notified body & health authority interactions and audits • Proven success in 510(k) Clearances, CE Certifications, Country specific registrations etc • 7+ years of experience in Medical Devices Industry.
Werdegang
Berufserfahrung von Adhithya Arumugasamy
Bis heute 9 Monate, seit Sep. 2023
Regulatory Affairs Manager
Siemens Healthineers
3 Jahre und 9 Monate, Jan. 2020 - Sep. 2023
Regulatory Affairs Specialist
Carl Zeiss India Pvt Ltd
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.,
1 Jahr und 10 Monate, Apr. 2018 - Jan. 2020
Senior Executive - Regulatory Affairs
Biocon Biologics Pvt Ltd
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
1 Jahr und 8 Monate, Sep. 2016 - Apr. 2018
Design Compliance Engineer
Perfint Healthcare Pvt Ltd
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)
1 Jahr, Sep. 2015 - Aug. 2016
Trainee - QA/RA
Perfint Healthcare Pvt Ltd
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
Ausbildung von Adhithya Arumugasamy
3 Jahre und 9 Monate, Aug. 2011 - Apr. 2015
Bachelor's of Engineering
Anna University, Chennai
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