Clinical Complaint Specialist
$80k - $100kFull-time
Danaher
Masimo seeks a Clinical Complaint Specialist to assess and process medical device complaints for regulatory compliance and product safety. The role involves clinical evaluation of adverse events, determination of regulatory reporting requirements, and investigation support in an on-site position in Irvine, California.
Responsibilities
- Review and process medical device complaints per regulatory and company requirements
- Perform clinical assessments to determine complaint severity and device-relatedness
- Evaluate regulatory reportability including MDR and global adverse event requirements
- Support complaint investigations and ensure accurate documentation
Requirements
- 3+ years clinical nursing or direct patient care experience
- Registered Nurse (RN) or Bachelor of Science in Nursing (BSN) degree
- Ability to interpret medical records and adverse event documentation
- Knowledge of FDA Medical Device Reporting (21 CFR Part 803)
- Experience with complaint handling or post-market surveillance preferred
- Medical device, biotechnology, or diagnostics industry background preferred
Compensation: $80,000-$100,000 base plus 10% target bonus
Vacancy posted 1 hour ago
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