Ashok Kumar Rajendran

Experience

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  Micro Therapeutic Research Labs Private Limited

  May 2018 - Dec 2018

  Research Associate-Quality control

  Conducted regular internal audits (Study, Facility, Process, etc.) to verify adherence to Standard Operating Procedures (SOPs), study protocols, and regulatory guidelines, including Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).Managed the calibration records of Clinical/Bioanalytical instruments and reviewed Pharmacokinetics data.Prepared and submitted technical data to the Institutional Review Board.Ensured compliance with regulatory requirements and maintained accurate records to facilitate audit readiness.Collaborated effectively with cross-functional teams and contributed to continuous improvement initiatives to enhance quality and efficiency. Show less

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  HCL Technologies

  May 2019 - Apr 2021

  Regulatory Engineer, Engineering, R&D

  As a Regulatory Affairs professional, I have extensive experience in Risk Management, Biological Safety Evaluation, Usability Engineering Evaluation, and Quality Management Analysis.My expertise in Risk Management includes identifying new requirements as per State of the Art, evaluating risk levels based on the worst-case severity and occurrence of harm rating, and reviewing design input to output documents for possible hazards. Additionally, I have experience in performing gap assessments in line with regulatory requirements for Usability Engineering Evaluation.In terms of Biological Safety Evaluation, I have verified MSDS for CMR identification and determined essential tests required for medical devices based on biological endpoints. I have also reviewed test reports to ensure compliance with regulatory requirements.My experience in Quality Management Analysis includes reviewing manufacturer's quality documents and manufacturing flowcharts, ensuring compliance with ISO 13485:2016 and State of the Art requirements.I have also performed MDD to MDR transition and prepared the Summary of Technical Documentation for notified body submission to ensure compliance with Medical Device Regulation 2017/745. In addition, I have evaluated the ASEAN regulations and prepared Common Submission Dossier Templates.With a strong background in regulatory affairs and a commitment to quality, I am confident in my ability to contribute to the success of the medical device industry. Show less

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  Tata Elxsi

  Apr 2021 - May 2024

  Experienced Medical Device Regulatory Specialist with a proven track record of ensuring compliance and successful market access for adiverse range of medical products.Proficient ininterpreting and applying complex regulatory guidelines to expedite product approval and launch processes. A dedicated professional specializing in Notified Body submission and coordination within the medical device industry.Strong communicator and problem solver,with a deep understanding of global regulatory frame works and standards. Dedicated to maintaining up-to-date knowledge of evolving regulations and industry trends.Skilled in projectmanagement, risk assessment, and quality assurance within the medical device sector. Committed to driving innovation while ensuring patient safety and product efficacy.Adept at coordinating all aspects of submissions, from compiling documentation to communicating with regulatory authorities and notified bodies. Show less As a Risk Management and Regulatory Affairs professional, I have successfully contributed to multiple projects related to medical devices. My areas of expertise include Failure Mode Effective Analysis (FMEA), verification and validation document preparation, and usability engineering.I have performed gap analysis on technical documents with respect to MDR 2017/745, and prepared Design Input and Output verification and validation documents. Additionally, I have prepared the Verification and Validation Summary (V & V Summary) and conducted gap analysis on EN 62366-1 usability engineering, while also preparing the User Interface of Unknown Provenance (UOUP) document.My experience also includes preparing the Summary of Technical Document for notified body submission, ensuring compliance with Medical Device Regulation EU MDR 2017/745. I have also worked on project management activities, such as defect reduction analysis on deliverables, and created a self-review checklist that ensures zero defects in work products.I have received customer appreciation for zero-defect deliveries on Risk Management files (AFMEA, DFMEA, Risk analysis worksheet, Risk management file, and Design matrix). Additionally, I have experience in review comments analysis and updating BSI submission files.I am a legal professional with a strong understanding of the regulatory landscape. I am committed to utilizing my skills and experience to contribute to the success of the medical device industry. Show less

  • Senior Engineer

    Jun 2023 - May 2024

  • Regulatory Engineer

    Apr 2021 - Jun 2023
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  Alcon

  May 2024 - now

  Regulatory Affairs Senior Specialist