Senior Specialist, Quality Assurance And Regulatory Compliance
Danaher UK
Shanghai, China
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Iso 14971 risk management application
Mdr and mir regulatory reporting
Root cause investigation leadership
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Danaher UK is seeking a Senior Specialist in Quality Assurance and Regulatory Compliance for their Shanghai office. The role involves leading technical complaint investigations, regulatory reporting, and collaborating with cross-functional teams in the medical device manufacturing sector.
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Job Summary
This role offers the opportunity to lead technical complaint investigations with cross-functional teams including sales, marketing, and engineering personnel.
The position requires applying principles of risk management in accordance with ISO 14971 to prioritize criticality of customer complaints and determine MDR reportability.
Join a winning team that partners with customers across the globe to solve complex challenges and architect solutions that bring the power of science to life.
Matching Summary
Match Score: 75
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Danaher UK is seeking a Senior Specialist in Quality Assurance and Regulatory Compliance for their Shanghai office. The role involves leading technical complaint investigations, regulatory reporting, and collaborating with cross-functional teams in the medical device manufacturing sector.
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Skills & Requirements
Must-have
ISO 14971 risk management application
MDR and MIR regulatory reporting
Root cause investigation leadership
CAPA structured problem solving
Microsoft Excel proficiency
Nice-to-have
Cross-functional team collaboration skills
Influence change outside local span
Build consensus with project teams
Strong written and oral communication
Scientific experimental planning expertise
Key Requirements
Bachelor's degree in science or engineering
Experience in medical device manufacturing quality roles