Job Description

Work Flexibility: Hybrid

What you will do-

  • Perform preliminary complaint intake, management, and event classification.

  • Conduct customer follow-ups and assess complaints for regulatory reportabilityin accordance withFDA 21 CFR 803, EU MDR 2017/745, and ISO 13485. 

  • Prepare and submit MDR, MIR, vigilance, and global adverse event reports, achieving zero late submissions.

  • Collaborate closely with stakeholders and team members, providing guidance and coaching to drive engagement and performance.

  • Demonstrate strong knowledge of Post-Market Surveillance requirements (US FDA and EU MDR), Quality Management Systems (ISO 13485, 21 CFR 820), and complaint handling tools such asTrackWiseor equivalent systems.

  • Experience withTrackWiseand Microsoft Project ; Post Market Surveillance as per US FDA & EU MDR ; Quality Ma...

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