Oct 2022 – Feb 2025 · 2 yrs 4 mos · Chennai, Tamil Nadu, India · On-site

• 🏆Spot Award winner for 2023 and 2024
• 🏆ERS Champion Award winner for 2023 and 2024
• 🏆Exceptional Performer for 2022 to 2024

Dec 2021 – Sep 2022 · 9 mos · Visakhapatnam, Andhra Pradesh, India · On-site

• Regulatory Compliance: Ensured the company’s products, manufacturing processes, and overall operations comply with the complex and ever-changing regulations set by health authorities like the FDA, EMA, and others. Handled product delays, recalls, or even regulatory enforcement actions.
• Successful Product Approvals: Prepared and submitted the comprehensive regulatory dossiers and applications required to gain marketing approval for new drugs, biologics, and medical devices. Expertise in navigating the regulatory landscape is essential for securing these crucial product approvals.
• Lifecycle Management: Even after a product is approved, I have played a crucial role in maintaining marketing authorizations, implementing post-approval changes, and leading lifecycle extension activities. This ensures the product remains compliant and can continue to be sold.
• Strategic Guidance: Provided strategic input to other departments like R&D, manufacturing, and quality on the regulatory implications of their activities. This helps the company make informed decisions and develop effective regulatory strategies.
• Preparing and Managing successful Quality audit (Internal/external) and Inspection
• APAC/LATAM/EMEA Regulatory submission and experience in USFDA, CE, UKCA, MDR, MDSAP and GCC countries
• Determining requirements (local, National, International) options for regulatory submissions, Approval pathway and compliance activities.
• Designed framework of National Medical Device Policy, New Drug, Medical device and cosmetic act 2022, Uniform medical device code for marketing Practices, Vision India 2047,India-International Bilateral Trade, WHO Pre-Qualification for IVD and regular interaction with DOP for Medical device Regulatory and Materiovigilance Projects  .
• BIS-Young professional and Ethics Committee Regulatory Approval

Apr 2019 – Dec 2021 · 2 yrs 8 mos · Chennai, Tamil Nadu, India

• Quality Management:
• Implementation of Medical device QMS through a Software package.
• Prepared Quality Manual which includes Framework for Continuous Quality improvement Process upon considering Total quality management
• Quality Assurance:
• Updated the SOP, Forms, and Checklist , Electrical safety Testing, CAPA.
• Patient Safety and Risk Management:
• Risk management Process in radiology and Electromechanical medical device based on the undesired event and key performance indicators.
• Framed risk management plan includes Risk Identification, Risk Evaluation, Risk Assessment, Risk Optimization, and Risk Control
• Created Medical Device Safety Guidelines
• Adverse event Handling
• Regulatory: Created appropriate forms and formats for Medical Device regulatory, standards, and Traceability.
• Clinical Investigation: Streamline SOPs, documents, and Forms to handle Clinical trials.
• Classification of Medical Device

Aug 2018 – Mar 2019 · 7 mos · Chennai, Tamil Nadu, India · On-site

• Worked in MDD to MDR Transition & Gap Analysis
• USFDA - Design Control - Verification and Validation
• QMS ISO13485:2016 Documentation and SOP preparation
• Risk Management ISO14971 Traceability Matrix, FMEA
• Medical device QA/RA Training