Nirav Bulsara Email & Phone Number

Pune, Maharashtra, India

My job responsibilities are as under:• Regulatory Submission Approval Planning, Monitoring and Control of Tasks and Milestones with Regulatory Team of oEU region.• Track and manage regional performance for oEU countries ensuring adherence to Monthly and Quarterly On-Time Submission• Approval Metrics for the Regulatory Teams of countries• Providing Consultative guidance to oEU countries in Planning and Control of On-Time License Renewals, Post Approval Changes, Regulatory Reporting and Query Handling from Drug Regulatory bodies,• Lead Project and Initiatives to support Country Regulatory team in Regulatory Changes Strategic Planning and Execution for Submission preparations, Dossier preparations, Global Trade Services (GTS) Regulatory Controls, Advertising Promotions, and publishing• Liase with Global Regulatory Counterparts and represent in various Change Advisory Boards including Regulatory Assessment, GTS, Regulatory Systems such as Liquent Insight, Documentum etc• Coordinate with cross geography stakeholders from Supply Chain, Regulatory, IT Systems, etc and resolution of Sales Order, STO or Delivery Blocks• Regulatory Operations Health and KPI Monitoring, Information Management and Analytics.• Weekly and Monthly Dashboard Management for Country Business Leaders

Pune, Maharashtra, India

My responsibilities are as under:• Lead the team of 15+ members involved in activities related to collaborating with various countries of APAC, EMEA, LATAM and OTHER region• Communicate and implement latest updates from the client with the team and also discuss the actions to be taken.• Incorporate the feedback received from Medtronic for the deliverables.• Keep the latest updates related to submission of all the region and discuss with the Project manager on daily basis.• Upload STED folder structure on RDR• Upfront Collaboration with Geo RA’s of various regions to fulfill the regulatory requirements for Neuromodulation and Pelvic Health products due to the impact of EU MDR Regulatory Submission Planning.• Creation of Geo Specific Documents, review and providing the inputs to the Geo RAs.• Preparation of country specific documents for the product and countries in scope.• Country Specific Regulatory Folder Creation.• Project deliverables review, Process optimization and Defect tracking.• Daily sync-up and Weekly status reporting.• Query resolution and MDR submissions schedule planning.• Internal meetings with team for performance evaluation and value add brainstorming.• Co-ordinate in resolution of queries related to various submissions documents internally for various geographies.• Co-ordinate in resolution of queries by reaching to the respective Geo RA if required. • Discussion with the Medtronic point of contact for any queries and clarifications with respect to the documentation provided and submission activities.• Co-ordinate with the onsite members for any updates and resolution received from the client. Analysis of the resolution and convey the same to the team.• Sync up twice a week with the Onsite coordinator for the query resolution as well as discussion.

Vapi, Gujarat, India

My job responsibilities are as under:• Prepare, review and update Technical Master File for CE submission in EU.• Prepare, review and update Device Master File for Medical device and IVDs for submission in Indian FDA as per MDR 2017.• Prepare, review and update Design History File.• Prepare, review and submit the Technical Dossier for various types of applications i.e. Wholesale license, Test license, Manufacturing license, Import license, Registration certificate, Clinical trial etc. as per time line on online portal "SUGAM".• Obtain quality certificates like Production Capacity/Market Standing/Performance/Non-Conviction etc. for taking part in various tenders.• Obtain certificate like FSC and Neutral code approval for export purpose.• Maintain and ensure document control systems and its adherence to applicable standards i.e. ISO 13485.• Co-ordinate during audits from Notified bodies as well as CDSCO/FDA related to product and facility.• Co-ordinate with Development, Production, QA/QC department for documentation required for filings of response to audit's non compliance.• Liaison with Local (Valsad), State (Gujarat) as well as Central FDA (Delhi & Ahmadabad) for Technical discussion regarding product permission of medical devices as well as IVDs.• Timely updates about any routine changes and update in SMF, Technical Master File, DHF etc.• Communicate and coordinate with regulatory personnel of different companies abroad for compilation of various documentations required for registration of their product meant to be imported in India.• Prepare Risk Management report as per ISO 14971, ESR and compile Clinical Evaluation Report etc. as per requirements by coordinating with Development, Production & Quality Control departments and performing literature reviews.• Co-ordinate with various departments for configuration of online QMS i.e. Matrix QMS system.• Vigilant for any regulatory changes occurring and their effect to the business.

Vapi, Gujarat, India

My job responsibilities are as under:• Prepare, review and update Technical Master File for CE submission in EU.• Prepare, review and update Device Master File for Medical device and IVDs for submission in Indian FDA as per MDR 2017.• Prepare, review and update Design History File.• Prepare, review and submit the Technical Dossier for various types of applications i.e. Wholesale license, Test license, Manufacturing license, Import license, Registration certificate, Clinical trial etc. as per time line on online portal "SUGAM".• Obtain quality certificates like Production Capacity/Market Standing/Performance/Non-Conviction etc. for taking part in various tenders.• Obtain certificate like FSC and Neutral code approval for export purpose.• Maintain and ensure document control systems and its adherence to applicable standards i.e. ISO 13485.• Co-ordinate during audits from Notified bodies as well as CDSCO/FDA related to product and facility.• Co-ordinate with Development, Production, QA/QC department for documentation required for filings of response to audit's non compliance.• Liaison with Local (Valsad), State (Gujarat) as well as Central FDA (Delhi & Ahmadabad) for Technical discussion regarding product permission of medical devices as well as IVDs.• Timely updates about any routine changes and update in SMF, Technical Master File, DHF etc.• Communicate and coordinate with regulatory personnel of different companies abroad for compilation of various documentations required for registration of their product meant to be imported in India.• Prepare Risk Management report as per ISO 14971, ESR and compile Clinical Evaluation Report etc. as per requirements by coordinating with Development, Production & Quality Control departments and performing literature reviews.

Vapi

My job responsibilities are as under:• Prepare, review and update Technical Master File for CE submission in EU.• Prepare, review and update Device Master File for Medical device and IVDs for submission in Indian FDA as per MDR 2017.• Prepare, review and update Design History File.• Prepare, review and submit the Technical Dossier for various types of applications i.e. Wholesale license, Test license, Manufacturing license, Import license, Registration certificate, Clinical trial etc. as per time line on online portal "SUGAM".• Obtain quality certificates like Production Capacity/Market Standing/Performance/Non-Conviction etc. for taking part in various tenders.• Obtain certificate like FSC and Neutral code approval for export purpose.• Maintain and ensure document control systems and its adherence to applicable standards i.e. ISO 13485.• Co-ordinate during audits from Notified bodies as well as CDSCO/FDA related to product and facility.• Co-ordinate with Development, Production, QA/QC department for documentation required for filings of response to audit's non compliance.• Liaison with Local (Valsad), State (Gujarat) as well as Central FDA (Delhi & Ahmadabad) for Technical discussion regarding product permission of medical devices as well as IVDs.• Timely updates about any routine changes and update in SMF, Technical Master File, DHF etc.

Vapi, Gujarat, India

My job responsibilities are as under:• Prepare and update Device Master File for Medical device and IVDs for submission in Indian FDA.• Prepare and submit the Technical Dossier for various types of applications i.e. Wholesale license, Test license, Manufacturing license, Import license, Registration certificate, Clinical trial etc. as per time line.• Obtain quality certificates like Production Capacity/Market Standing/Performance/Non-Conviction etc. for taking part in various tenders.• Obtain certificate like Free Sale certificate and Neutral code approval for export purpose.• Co-ordinate during audits from CDSCO/FDA related to product and facility.• Co-ordinate with Development, Production, QA/QC department for documentation required for filings of response to audit's non compliance.• Timely updates about any routine changes and update in Quality Manual, Site Master File, Technical Master File, Quality Procedure etc.

India

My job responsibilities are as under:• Prepare and update Device Master File for Medical device and IVDs for submission in Indian FDA..• Prepare and submit the Technical Dossier for various types of applications i.e. Wholesale license, Test license, Manufacturing license, Import license, Registration certificate, Clinical trial etc. as per time line.• Obtain quality certificates like Production Capacity/Market Standing/Performance/Non-Conviction etc. for taking part in various tenders.• Obtain certificate like Free Sale certificate and Neutral code approval for export purpose.• Co-ordinate during audits from CDSCO/FDA related to product and facility.

M.B.A., Operations Management And Supervision

Ccna, Mcp, Mcsa, Networking

B.E, Electronics And Communication Engineering

Matriculation, Science

Activities and Societies: • Participated in relay race, tug-off war, march past during sports day.

Primary And Secondary Education, Matriculation

Nursery And Primary Education, Kindergarten/Preschool Education And Teaching