Shibabrata Bhattacharyaya
Regulatory Affairs & Quality Assurance | Medical Device Expert | ISO 13485:2016, EU MDR, MDSAP | DQS-Certified Internal Auditor | Global Market Compliance (USFDA, EU, Middle East, ASEAN)
- Role
- Regulatory Aaffairs at Periwinkle Technologies
- Location
- Pune District, MH, IN
- LinkedIn followers
- 500 followers
About Shibabrata Bhattacharyaya
With over 13 years of hands-on experience in the medical device and life sciences…
Experience
Regulatory Aaffairs
Jun 2023 — Present · Pune, IN
Medical device registration in global countries like USFDA 510k, Middle East and ASEAN.Handling Class B device for CDSCO approvalCoordinate with the Medical Device representative in different countries to ensure registration requirement are fulfilled until the final phase.Preparation and review of SOP’s, specification and protocol as per the ISO 13485, requirements with respect to quality control activities.Participated in ISO 13485 internal auditor and perform an internal audit.Medical device registration in global countries.
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