Seetha A

Experience

• 

  TTK HEALTHCARE LIMITED

  Apr 2021 - Sept 2021

  Regulatory affairs trainee

  EU Trend Analysis, CER, RMR, ISO 13485, Complaints Handling, Risk mitigation, Adverse events

• 

  HCLTech

  Dec 2021 - now

  Preparation of Product Performance Analysis reports for all type of medical device classes. Preparation Periodic Safety Update Report to submit EU MDR. Preparation Health Canada Summary Update to submit Health Canada Regulations. Documentation of Final Inspection Report for all the finalized reports. Process owner for complaints handling. Reporting of MDR for submission to FDA if incident needs reportability criteria as per 21 CFR 803. Investigating the complaint and categorizing and the complaint and reporting to FDA by IMDRF codes. Hands on experience in handling Trackwise, MasterControl and SAP tools.

  • Gen Regulatory Engineer

    Nov 2022 - now

  • Quality Analyst Engineer

    Dec 2021 - Oct 2022