Job Summary
A company is looking for a Senior Manager, Clinical Product Quality - Post Market Quality & Complaints.
Key Responsibilities
- Provide medical/clinical guidance to complaint staff and engineers regarding event interpretation and regulatory reporting
- Review and approve global reporting decisions and complaints for closure
- Analyze and interpret complaint data, preparing responses for regulatory and internal requests
Required Qualifications
- Bachelor's degree in nursing, scientific, or quality-related field with a minimum of 10 years of relevant experience, or a Master's degree with a minimum of 8 years of experience
- Experience in the medical device industry, quality systems, or clinical settings
- Supervisory or people leadership experience
- Registered nurse with a current state license in good standing
- Proven experience with complaint handling and managing Medical Device Reporting (MDR)
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