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Regulatory affairs professional with strong expertise in regulatory compliance, documentation, and submission processes. Known for effective collaboration with cross-functional teams and results-driven approach. Skilled in regulatory strategy, risk assessment, and ensuring adherence to industry standards. Adaptable and reliable, excelling in dynamic environments. Seeking opportunities to contribute to successful regulatory strategies in Medical Device, Biotech and Pharmaceutical industry.

Experienced Product Complaint Professional with over 2 years of expertise in product complaint investigation, adverse event analysis, and regulatory reporting. Consistent in evaluating safety data and determining reportability. Strong background in cross-functional collaboration with Quality, Regulatory, and Medical Affairs teams to ensure accurate and timely Medical Device Reporting (MDR), and support post-market surveillance activities.


  Accomplished PMS Analyst at HCL Technologies, adept in Medical Device Regulatory Affairs (FDA) and Quality Assurance, significantly enhanced team productivity and reduced project risks. Expert in MS Excel and Documentation, my strategic risk assessments and mitigation strategies streamlined compliance processes, ensuring excellence in handling medical device complaints.
  Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.


Organized and dependable Process Analyst with a proven ability to manage multiple priorities efficiently. Skilled multitasker with a strong work ethic, teamwork, and problem-solving abilities. Expertise in healthcare claims processing, regulatory compliance (HIPAA, HITECH, EMTALA), complaint Handling and quality control. Dedicated to maintaining accuracy, confidentiality, and process improvement while mentoring new recruits. Reliable and resourceful team player, committed to delivering high-quality results.

Gayathri Tirumalanadhuni

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PMS Analyst

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B Pharmacy - Bachelor of Science

Intermediate -

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PMS Analyst

B Pharmacy - Bachelor of Science

Intermediate -

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