• Maintain and improve the Post Market Surveillance (PMS) system to ensure compliance with relevant regulatory requirements.

• Support the complaint handling process, including complaint initiation, investigation, and documentation of findings.

• Conduct reportability assessments and prepare adverse event reports for submission to regulatory authorities (US FDA, EU MDR/MDD, PMDA, etc.).

• Participate in the development and update of PMS plans, PMS reports, and Periodic Safety Update Reports (PSUR).

• Analyze post-market data, identify complaint trends, and recommend corrective and preventive actions as needed.

• Collaborate with cross-functional teams, including Quality, Risk Management, and Regulatory Affairs, to update risk management files based on PMS data.

• Prepare documentation and reports for internal management reviews, regulatory audits, and external customer inquiries.

• Assist in identifying potential CAPA/SCAR actions and ensure timely implementation of improvements.

• Interact with regulatory bodies and customers regarding post-market compliance matters.

Qualification