Hasan Shazuli

About Hasan Shazuli

Biomedical Engineering graduate currently working as a Post Market Surveillance (PMS) Analyst in the Medical Device domain at HCL Technologies.With hands-on experience in complaint handling, root cause analysis (RCA), risk assessment, and regulatory documentation, I contribute to ensuring patient safety and global regulatory compliance across post-market activities. My work involves investigating device-related issues, supporting vigilance reporting, and aligning processes with international standards including FDA guidelines and quality system requirements.Through advanced medical equipment training and real-time industry exposure, I have developed a strong understanding of the medical device lifecycle - from risk management and post-market monitoring to continuous quality improvement. I actively contribute to compliance processes that strengthen product safety and regulatory adherence.I am particularly focused on building expertise in Regulatory Affairs, Clinical Data Management, and Global Medical Device Compliance (FDA, EU MDR, ISO 13485). My goal is to contribute to international healthcare systems by upholding high standards of safety, accountability, and regulatory excellence.Open to global opportunities, cross-functional collaboration, and roles within Regulatory Affairs, Quality Management Systems, and Post-Market Compliance.

Experience

1. Post-market Surveillance Analyst

   HCLTech

   Feb 2025 — Present · Madurai, IN

   Investigate post-market medical device complaints and document findings in alignment with FDA regulatory guidelines.• Perform root cause analysis (RCA) to evaluate device-related issues and support risk assessment activities.• Review and process complaint tickets within defined timelines while ensuring data accuracy and regulatory compliance.• Support vigilance reporting and documentation for global regulatory submissions.• Collaborate with cross-functional teams including Quality, Regulatory, and Technical departments to ensure timely resolution of product safety concerns.• Maintain detailed records to support audit readiness and quality system requirements.• Contribute to continuous improvement initiatives by identifying recurring trends in complaint data.

Education

• Harvey Biomedical

  Biomedical Engineer, Application Of Medical Devices

• Velammal Vidyalaya Viraganoor

  Secondary education , General Studies

• Velammal bodhi campus Anuppanadi

  Higher secondary education , Biology, General

• Sethu Institute of Technology

  Bachelor of Engineering - BE, Bioengineering and Biomedical Engineering