Clinical Complaint Specialist — Medical Devices & MDR

Danaher; Irvine (CA); On-site; USD 80,000 - 100,000; Full time

Job summary

Masimo, a Danaher operating company, seeks a Clinical Complaint Specialist to assess and process medical device complaints for regulatory compliance and safety. The role is on-site in Irvine, CA, reporting to the Director of Quality Customer Complaints.

You will evaluate severity, potential patient impact, and device-relatedness, while supporting investigations and accurate documentation. RN/BSN or equivalent required.

Qualifications

• 3+ years of clinical nursing or direct patient care experience.
• Registered Nurse (RN), Bachelor of Science in Nursing (BSN), or equivalent clinical degree.
• Ability to interpret medical records, clinical documentation, and adverse event information.

Responsibilities

• Review, evaluate, and process medical device complaints in accordance with regulations, procedures, and quality system requirements.
• Perform clinical assessments of complaint events to determine severity and patient impact.
• Evaluate complaints for regulatory reportability, including MDR and vigilance reporting.

Skills

Clinical nursing

Direct patient care

Regulatory awareness

Medical record review

Education

RN/BSN or equivalent

Job description

Masimo, a Danaher operating company, seeks a Clinical Complaint Specialist to assess and process medical device complaints for regulatory compliance and safety. The role is on-site in Irvine, CA, reporting to the Director of Quality Customer Complaints.

You will evaluate severity, potential patient impact, and device-relatedness, while supporting investigations and accurate documentation. RN/BSN or equivalent required.