Dolly Sharma

Experience

• 

  Meril

  Jul 2012 - Nov 2015

  Sr officer QA/RA

  QMS & Regulatory affairs for Healthcare, Endosurgery, IVD business units. Overall QMS handling, Preparation of SOP, Protocols, and all other documents related to ISO 13485. Preparation of Technical documents. Handling QA activities and conducting Internal Audits across divisions.

• 

  Jai Pharma Ltd (Mylan subsidiary)

  Nov 2015 - Jan 2017

  QA Executive and Management representative

  Preparation of SOP, Protocols, and all other documents related to ISO 13485& ISO 9001:2008. Preparation of Technical documents. Handling QA activities.Co-ordination with notified bodies, facing audits and responding to queries

• 

  SLTL Group - Sahajanand Laser Technology Ltd

  Jan 2017 - Mar 2018

  Assistant Manager Quality Assurance and Regulatory Affairs

  Provide ISO 13485, GMP, GDP and other regulation guidelines relatedtraining to plant employees throughout the year. Preparation of Technicaldocuments & Training to employees. Audit Facing, NB communication, responding to NB queries, implementation of CAPA

• 

  Maven Profcon Services LLP

  Apr 2018 - Dec 2020

  Expertise in Orthopedic implants CE marking. Consulting for MDASP andCanadian regulations. Trained on MDR. Conducting MDR gap analysis ofcompanies for transition planning and implementation, Consulting clients onMDR & providing training for the same. Conduct mock Audits for preparingthem for External audit.

  • General Manager

    Jan 2019 - Dec 2020

  • Regulatory Manager

    Apr 2018 - Jan 2019
• 

  TÜV SÜD

  Jan 2021 - Mar 2023

  MHS Lead Auditor

  ISO 13485, ICEMED 13485, MDD, MDR Auditor, provides technical supports to the business development / sales team as needed at the all stages of the project, and scheduling projects including audits, TD assessment well in advance. Ensure the implementation of the ISO 19011:2018 and ISO 17021:2011.Trainer for ISO 14971, Internal Auditor - ISO 13485, Lead Auditor ISO 19011 & ISO 13485, Biocompatibility awareness training.

• 

  Tata Elxsi

  Aug 2023 - now

  Seasoned professional with a proven track record of success in the field of Medical device regulatory and possess sound knowledge in overall regulatory requirements of Medical Devices regulations. Quality Assurance & End to End Documentation knowledge for EU, US & India regulatory requirements. Also QMS documentation as per MDSAP. Medical Devices Regulatory & QMS Expert with10yrs of experience including EU MDR 2017/745,ISO 13485, ICEMED 13485, MDSAP, MDD & IVD.Also, Trainer for Regulatory related subjects

  • Practice Lead

    Jul 2023 - now

  • Senior Regulatory Associate

    Aug 2023 - Jan 2024