Adarsh Anand

Experience

• 

  Maven Profcon Services LLP

  Jul 2021 - Jun 2023

  1. Project Lead of teams to perform CE, MDSAP and ISO 13485 audit preparation & support on site and off-site2. Medical Device Internal audits3. Periodic documentation updates of Post-Market Surveillance as per regulatory requirements, including PSUR and PMCF summary reports along with data analysis4. Oversee QMS documentation as well as implementation in multiple manufacturing units5. Risk management as per ISO 14971:2019 documentation and implementation6. Review country-specific registration document dossiers and submissions7. Resolve queries from regulatory authorities (technical reviews) and clients8. Offline, Online and On the Job Training of clients and employees on various aspects of ISO 13485:2016, Regulation (EU) 2017/745, MS Office, Communication9. EU MDR Technical File Preparation10. Review and update Clinical Evaluation Reports11. Client Communication, technical conflict resolution and organize site visits12. Development of effective templates for Task Management13. Perform RND on the inter-relation of processes to develop a matrix for QMS software algorithm development14. Blog Writing on regulatory hot-topics15. Content creator for Regulatory Affairs Digital Marketing - including script writing, post writing as well as video and audio recording, editing and direction for LinkedIN and Youtube promotional content16. Management of Premium Annual Contract Clients Show less 1. Project Lead of teams to perform CE and ISO 13485 audit preparation on site and off-site2. Internal audit as per ISO 13485:2016, I MDR, CE and ISO 9001:20153. Periodic documentation updates of Post-Market Surveillance as per regulatory requirements, including PSUR and PMCF summary reports along with data analysis4. Preparation & maintenance of QMS documentation as well as implementation in multiple manufacturing units5. Risk management as per ISO 14971:2019 documentation and implementation6. Country-specific registration document dossiers and submissions7. Query resolution from regulatory authorities (review comments) and clients8. EU MDR Technical File Preparation for active and non-active devices9. Clinical Evaluation for low risk, moderate risk and high risk devices10. Performance and Safety Principle Checklists - EU MDR, TGA, I MDR, Saudi FDA, EC MDD11. Client Communication and Technical conflict resolution12. RND on existing documentation templates and system functioning; provide automation/semi-automation based solutions13. Persuasive presentations to highlight and resolve internal and external issues of an organization to improve efficiency14. Blog-writing on regulatory hot-topics Show less

  • Sr. Regulatory Affairs Executive

    Apr 2023 - Jun 2023

  • Jr. Regulatory Affairs Executive

    Jul 2021 - Apr 2023
• 

  RegTrac

  Nov 2023 - now

  Team Lead, Regulatory Affairs

  I'm dedicated to ensuring compliance and fostering innovation, contributing to the growth of a dynamic startup.