Vinoth Kumar Email & Phone Number

Designation: Senior Quality Management & Regulatory Affairs Specialist Quality Management : ISO 13485 lead Auditor, ISO 9001, ISO 17025 Internal Auditor , CAPA Site lead IMEA, Complaint Management officer, Implementation of new QMS, intneral Audit, RoHS, REACH IEC 63000.Supporting all Registrations for EU and Rest of the world countries Which will include Saudi Arabia, Kuwait, South Africa, UAE, Israel, Turkey, Egypt, Oman, South Korea, Japan, Malaysia, India, Srilanka, for IVD Regulatory Specialist – Supporting all Registrations for FDA , EU and Rest of the world countries Which will include Canada, Russia, South East Asia like malaysia, Singapore India• Preparation of Complete Submission Dossier for all the above-mentioned products for every NPI of Ultrasound Products. NPI will include both Hardware and Software Releases.• Regulatory submission will also include Preparation of Requirement checklists and all the associated Evidences right from Device specification, Requirements to Risk analysis, Verification and Validation.• Submission of GTIN for All NPI in the GUDID Database• Preparation of all country specific Requirements according to the Country’s Requirement.• Strategical Submission of Dossiers to enhance quicker approval time line.• Preparation of IFU’s, Operation Notes from third party and verifying it for timely release for new updates.• Preparation and Maintenance of Internal Log for all the Clearances and licenses that are valid for Philips Globally.• Preparation of internal Quality and risk procedures based on the global Philips ISO 14971 Compliant Manual.Expertise in Regulatory Standards of Country wise RequirementsThe Registrations has also demanded type testing in few specific markets were as many accepted the Global standards of IEC 60601 -1, IEC 60601-2-37, IEC 60601-1-6. The other standards, type testing, in which I have been involved are• South Korean EMC testing Standards & South Korean Type testing to check the Safety of the Medical Device(KGMP)• Experienced in Applying for EU FSC ( Free sale Certificate) & US CFG ( Certificate for Foreign Government)Other Continuous Improvement Activities• Creation of Automatic Tool to collect and compile Various Requests for Registration received from Various Key Markets. This tool will automatically assign the right person to take up the task and will provide metrics every end of the month. The tool is created with Microsoft Power Apps.• Created a Collaborative Share point where all the common Documents like EU FSC, CFG can be shared quick.

Listed skills include Microsoft Excel, Microsoft Word, Powerpoint, Customer Service, and 17 others.