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Compliance Engineer II, EUMDR
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- Our partner, a best-in-class medical device manufacturer, is hiring for multiple EU MDR Compliance Engineer roles.
- The EU MDR Compliance Engineers will be responsible for ensuring that products comply with the European Union Medical Device Regulation (EU MDR) and other relevant regulatory requirements.
- The Engineer will support the management of Health Hazard Evaluations, track of EU MDR deliverables, support cross-functional project team with compliance related decisions/interpretations, and evaluate impact of standard/regulation updates to existing product families and QMS processes.
- Preparing and reviewing regulatory submissions for the European market, including Technical Documentation, Clinical Evaluation Reports, and Post-Market Surveillance Reports.
- Conducting gap analyses to identify areas of non-compliance with MDR and developing remediation plans to address any deficiencies.
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