Jaishri Meganathan
Medical Device Regulatory Affairs professional
- Role
- Senior Regulatory Affairs Specialist at Philips
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Jaishri Meganathan
Responsible to ensure the Product compliance as per medical device regulation worldwide. To ensure timely Product Registration as planned. Expertise in EU MDR, Clinical Evaluation as per MEDDEV guidance, MDR & as per ISO 14155, Labeling.Worked on Multiple FDA Submissions including De Novo, Pre subs and CE mark.Responsible to develop Tech file for CE marking as both MDD & EU MDR, DMR for USFDA - Traditional & Special 510(K) Submissions, De Novo Submission, Pre-Sub etc and documentation for worldwide product registrations.Experienced in USFDA, CRDH - Quality System Requirements according to 21 CFR 820, PMS - 21 CFR 822, Medical Device Reporting - 21 CFR 803 & 806 FDA Form 483 Inspectional Observation.Experienced in CE marking as per MDD & EU MDR for Active Medical device, stand-alone CDS software and Interacting with the Notified Body.Responsible for handling Design and Development & Management Representative periodic Internal / External Audits as per ISO 9001, ISO 13485, and product based regulatory audits from FDA and CE - notified body.Have work experience in cross function area - Quality Control, Procurement, Production, Supply Chain.Responsible to support & guide the team for new product development.Responsible to collect data from PMS for new improvements.Responsible to conduct MRMResponsible to do Process Validation and writing Validation Protocol & Report for the product development and testing equipment in line with 21 CFR 820 and ISO 13485.Responsible for Document Control and Records.
Experience
Senior Regulatory Affairs Specialist
Jan 2026 — Present · Bengaluru, IN
Education
Anna University Chennai
Bachelor’s Degree, Biomedical Engineering
2010 — 2014
Velammal Matriculation Hr. Sec School
High School, Maths, Biology
2010
Institute of Good Manufacturing Practices India
Post Graduate Diploma, Post Graduate Diploma in Medical Device Management (Regulatory Affairs)
2016 — 2017
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