Job Description
**What you will do-**
**P** **erform preliminary complaint intake, management, and event classification.**
**Conduct customer follow-ups and assess complaints for regulatory reportability** **in accordance with** **FDA 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 as** **TrackWise** **or equivalent systems.**
**Experience with** **TrackWise** **and Microsoft Project** **;** **Post Market Surveillance as per US FDA & EU MDR** **;** **Quality Management (ISO 13485 or 21 CFR 820 ; working with multiple teams ...
**P** **erform preliminary complaint intake, management, and event classification.**
**Conduct customer follow-ups and assess complaints for regulatory reportability** **in accordance with** **FDA 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 as** **TrackWise** **or equivalent systems.**
**Experience with** **TrackWise** **and Microsoft Project** **;** **Post Market Surveillance as per US FDA & EU MDR** **;** **Quality Management (ISO 13485 or 21 CFR 820 ; working with multiple teams ...
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