Vishnu Vyas Email and Phone Number
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Over 20 years working with Medical Devices companies in variety of assignments ranging from regulatory affairs and quality assurance. Active in standards development and harmonization process through his participation in various ISO and CEN technical committees on sterilization and packaging. Expert nominated to ISO TC198/WG7 “Sterilization of Health Care Products—Packaging” (ISO 11607) & WG9 ‘Aseptic Processing’ by BIS, India. Actively involved in regulatory policies framework development in AP region through his engagement with MedTech trade associations. Specialties: Medical Devices Regulatory Strategy, Standards Development, Public Policy Deliberations, Project Managements.
Mtai (Medical Technology Association Of India)
View- Website:
- mtaiindia.org
- Employees:
- 11
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Co-Chair: Quality Assurance And Standards Committee (Honorary Role)Mtai (Medical Technology Association Of India)Delhi, India -
Ap Leader Regulatory, Govt Affairs & Standards- Dupont™ Tyvek® Healthcare PackagingDupont Aug 2017 - PresentNew Delhi Area, India1. Member of the global Healthcare Regulatory & Standards core team.2. Responsible for the regulatory & standards strategy for DuPont Healthcare in India and ASEAN countries.3. Member of ISO/ TC 198 'Sterilization of Healthcare products', India representative (BIS nominated) to ISO/ TC 198 WG 7 'Packaging' as subject matter expert on sterile packaging.4. Responsible for effective relationship management with targeted Regulators, professional influencers and thought leaders in the broader industry and its stakeholders.5. DuPont representative at Medical Devices industry associations in India and ASEAN.6. Active in developing a regulatory roadmap & knowledge base to identify key regulatory issues, stakeholders, activities and events for AP. -
Head Of Regulatory Affairs & Govt Affairs, South AsiaB. Braun Group Sep 2016 - Aug 2017New Delhi Area, India1. To manage overall Regulatory, Quality Assurance and Public Policies activities at B. Braun Group India level, including 03 manufacturing units (located at Bhiwadi, Rajasthan; Medchal, Telangana & Chengalpet, Tamilnadu) & at corporate level.2. To ensure on-going regulatory and product safety compliance of B. Braun product portfolio in India.3. Develop and manage a stable and effective regulatory team in the region as a business partner. 4. Positively influencing external regulatory environment of the country to assure the scientific-sound and business-sensible principles are implemented in all the country policy/ regulations related to B. Braun business.5. Monitor & do the impact analysis of new pricing policies from the govt. of India on B. Braun ranges of products. -
Head Of Regulatory Affairs And Govt Affairs, South AsiaEdwards Lifesciences Oct 2012 - Aug 2016New Delhi Area, India1. Responsible for completion of all the work related to complying with all the regulatory and quality requirements for products the company wishes to distribute in the Greater India- India, SriLanka, Bangladesh and Nepal market. 2. To build an effective compliance infrastructure to meet all regulatory and quality requirements and mitigate compliance risk.3. To ensure the appropriate licensing, marketing and legal compliance. Combining knowledge of scientific, legal and business issues to enable products distributed meet and relevant laws and regulations of the GI market.4. Responsible for ensuring regulatory and quality compliance at all levels, both of the GI market and within the company, understanding new regulations, handling new product registration and licence renewal registration, complaints handling and field actions and training of other RA associates.5. Responsible for representing the company in industry associations (FICCI, AmCham, AdvaMed, CII) to lobby the government for a more favorable market environment for the company to develop its businesses in various GI countries. -
Regulatory Affairs ManagerMedtronic Apr 2012 - Sep 2012New Delhi Area, India1. To manage Regulatory Affairs function for Medtronic India with a complex matrix environment.2. To prepare and follow the Standard Operating Procedures and proper work flow for RA department to ensure smooth running of RA function for sustainable growth of organization.3. Regular visits to the concern regulatory bodies to do the follow-ups of ongoing regulatory projects and to provide technical inputs to regulators related to our products wherever required. 4. Positively influencing external regulatory environment of the country to assure the scientific-sound and business-sensible principles are implemented in all the country policy/ regulations related to Medtronic business. -
Regulatory Affairs SpecialistBecton Dickinson India Pvt. Ltd. Mar 2009 - Mar 2012Gurgaon, India1. To prepare and submit the regulatory dossiers for imported products as per guidance provided by the Manager- Regulatory Affairs.2. To ensure timely approvals of new registrations and launch of these products in India by providing post approval support i.e. India specific labeling from source & working with SCM team to ensure the smooth clearances of the product consignments.3. To provide required support to local manufacturing site on regulatory matters i.e. manufacturing license for indigenously manufactured products etc.4. To help and facilitate India manufactured products registrations in various Asia Pacific countries i.e. Philippines, Singapore, Thailand etc. 5. Regular visits to the concern regulatory bodies i.e CDSCO, local FDAs to do the follow-ups of ongoing regulatory projects and to provide technical inputs to regulators related to our products wherever required. 6. Positively influencing external regulatory environment of the country to assure the scientific-sound and business-sensible principles are implemented in all the country policy/ regulations related to Medtronic business. -
Senior Regulatory Affairs SpecialistMax Neeman International Jan 2007 - Feb 2009Delhi1. Part of regulatory team to help & support achieving timely submissions and approval for the Clinical Studies applications for new chemical entities. 2. Handling regulatory affairs for Phase-I to Phase- IV clinical studies related to Drugs and Medical Devices.3. In-charge of in-house pharmacy of Max Neeman for the storage of Clinical Trial materials related to on-going clinical studies.4. Regular interactions with regulatory bodies i.e Ministry of Health, CDSCO, DGFT etc to get the CT permissions.5. Regular interactions with clients to update them of regulatory status of their going studies.
Vishnu Vyas Skills
Vishnu Vyas Education Details
Frequently Asked Questions about Vishnu Vyas
What company does Vishnu Vyas work for?
Vishnu Vyas works for Mtai (Medical Technology Association Of India)
What is Vishnu Vyas's role at the current company?
Vishnu Vyas's current role is Co-Chair: Quality Assurance and Standards Committee (Honorary Role).
What is Vishnu Vyas's email address?
Vishnu Vyas's email address is vi****@****rds.com
What schools did Vishnu Vyas attend?
Vishnu Vyas attended Birla Institute Of Technology And Science, Pilani, Mohanlal Sukhadia University.
What are some of Vishnu Vyas's interests?
Vishnu Vyas has interest in Children, Civil Rights And Social Action, Education, Disaster And Humanitarian Relief, Human Rights, Health.
What skills is Vishnu Vyas known for?
Vishnu Vyas has skills like Regulatory Affairs, Medical Devices, Pharmaceutical Industry, Fda, Clinical Trials, Regulatory Submissions, Regulatory Requirements, Gmp, Quality Assurance, U.s. Food And Drug Administration, Capa, Validation.
Who are Vishnu Vyas's colleagues?
Vishnu Vyas's colleagues are Dr Divya Tayal, Shubham Mohite, Piyush Sharma, Mtai Secretariat.
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