Vignesh Kumar
Regulatory Affairs Professional having experiences in registeration of devices in different jurisdiction.
- Role
- Regulatory Affairs Specialist at NeilMed Pharmaceuticals
- Location
- Chennai, TN, IN
- LinkedIn followers
- 500 followers
About Vignesh Kumar
Experienced Regulatory Affairs professional with a demonstrated history of working in the…
Experience
Regulatory Affairs Specialist
Sep 2022 — Present · Bengaluru, IN
Registration of Medical Devices in global markets like US, Europe, TGA-Australia, New zealand, Saudi, Canada etc, Applying FSC application in CDPH portal for the Various regions for the country. Created the Protocol & Verification report for the product as per ASTM D7661-18. CE Marking procedure, Registering, and listing, 510K Notification, Annual Licensing, Device registration in different authority. Establishment and Registration licenses renewal for all product portfolios. Complying with ongoing Global Regulatory Requirement to sustain our products in different markets and to inform Competent Authorities in case of any changes. Document change control release (DCR’s) for any change or update in any jurisdictions. Review of Labels as per different jurisdictions. Classification of Medical devices as per different jurisdictions. Direct Communication to different stake holders, Notified body, health authorities and Authorized representatives for submission and compliance handling. Involved in ISO Audits with respective to regulatory (13485, BSI & Intertek audits) Tracking of each Regulatory license and renewal process. Creation of technical Documents to register the products globally. Representing Regulatory team in Notified Body and Health Authority Audits such as TUV QMS Audit, TUV Surveillance Audit, Health Canada Site Audit. Transiting our products from MDD to MDR including classification assessment, selection of conformity assessment, Gap Assessment, applying for Liability Insurance. Documenting STED file to apply CE mark with respect to MDR 2017/745.
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