Kumaran K
Certified Lead Auditor for ISO 13485:2016|MDR Submission for Class IIB& III Implants| Registered 30K plus products in the international markets| Well-versed with 21 CFR Part 820, EU MDR, US FDA, ISO 14971:2019.
- Role
- Regulatory Affairs Specialist at Medtronic
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Kumaran K
Accredited Lead Auditor for ISO 13485:3016. Hands-on Experience on Product…
Experience
Regulatory Affairs Specialist
Dec 2022 — Present · Hyderabad, IN
Performing Regulatory assessment for changes (RAC) for every change order like ECC, PCH, RCH, SCC, and DVN initiated at SIMA (Medtronic, DR)2. Created MDR Classification, Declaration of Conformity (DoC), General Safety and Performance Requirement (GSPR) documents for MDR Submission to Notified Body (NB)3. Supported an Internal and Notified Body Audit for QMS compliance and MDR Product Surveillance Audit.4. Registered Class Neuroscience products (CSF Shunt) in the international market.5. Providing Regulatory support to lift US FDA Form 483 (Observation Letter) by initiating remediation projects.6. Audit Support for Non-Conformance Report and Lab Team for QMS compliance at MEIC Hyderabad.
Education
New Prince Shri Bhavani College Of Engineering And Technology
Bachelor of Engineering - BE
2012 — 2016
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