Responsibilities

Implement and maintain the PMS system in accordance with ISO 13485, applicable regulatory requirements, EU MDR 2017/745, and other applicable market regulations.

Prepare, review, and maintain PMS plans, PMS reports, Periodic Safety Update Reports (PSURs), and Post-Market Clinical Follow-up (PMCF) documentation, as applicable.

Collect, monitor, and analyse post-market data, including customer feedback, complaints, product performance, literature, and field safety information.

Perform trend analysis to identify recurring complaints, emerging risks, and potential product safety concerns.

Coordinate with Regulatory Affairs, Quality Assurance, R&D;, Manufacturing, and Clinical teams for PMS activities.

Maintain traceability between PMS findings, risk management files, clinical evaluation, and product improvement activities.

Ensure timely preparation and submission of applicable post-market reports to regulatory authorities and Notified Bodies.

Receive, register, acknowledge, classify, and investigate customer complaints related to medical devices.

Assess complaints for severity, patient impact, product performance, and potential safety risks.

Coordinate complaint investigations with relevant departments and suppliers to determine the root cause.

Review returned products, samples, photographs, batch records, manufacturing history, and test reports, where available.

Conduct root cause analysis using tools such as 5 Why,



Fishbone Analysis, and Fault Tree Analysis.

Initiate and monitor Corrective and Preventive Actions (CAPA) to address identified issues and prevent recurrence.

Ensure timely communication with customers regarding investigation progress, findings, and corrective actions.

Prepare investigation reports and maintain complete complaint records in accordance with established procedures.

Monitor complaint closure timelines and ensure effective implementation of corrective actions.

Evaluate complaints for reportability under applicable vigilance requirements.

Coordinate investigation and reporting of responsible incidents, adverse events, and field safety issues.

Support preparation of Field Safety Corrective Action (FSCA) documentation and Field Safety Notices (FSNs), where applicable.

Ensure compliance with applicable reporting timelines under EU MDR, Indian Medical Device Rules, and other relevant regulations.

Coordinate with Regulatory Affairs for regulatory submissions, follow-up reports, and responses to authority queries.

Qualifications

Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, or a related discipline.

Experience in medical device Quality Assurance, complaint handling, PMS, or Regulatory Affairs.

Practical experience in CAPA, root cause analysis, risk management, trend analysis, and regulatory documentation.

📌 Executive / Assistant manager - Customer Complaints (Dehradun)
🏢 Translumina Therapeutics
📍 Dehradun