The Clinical Complaint Specialist is responsible for the clinical assessment, evaluation, and processing of medical device complaints in support of regulatory compliance and product safety activities. This role applies clinical expertise to evaluate complaint events, assess potential patient impact, determine regulatory reportability, support investigations, and ensure accurate complaint documentation.

This position reports to the Director, Quality Customer Complaints and is part of the Quality Compliance team located in Irvine, CA and will be an on-site role.   

In this role, you will have the opportunity to: 

• Review, evaluate, and process medical device complaints in accordance with applicable regulations, company procedures, and quality system requirements.
• Perform clinical assessments of complaint events to determine severity, potential patient impact, and device-relatedness.
• Evaluate complaints for regulatory reportability, including Medical Device Reporting (MDR), vigilance reporting, and other applicable global adverse event reporting requirements.

The essential requirements of the job include:

• 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.

It would be a plus if you also possess previous experience in: 

• Experience in the medical device, biotechnology, pharmaceutical, diagnostics, or healthcare industry.
• Experience with complaint handling, adverse event reporting, post-market surveillance, or quality systems.
• Knowledge of FDA Medical Device Reporting requirements (21 CFR Part 803), complaint handling requirements (21 CFR Part 820), and applicable international vigilance regulations.

Masimo, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. 

The annual salary range for this role is$80,000 - $100,000. This is the range that we in good faith believe is the range ofpossible compensationfor this role at the time of this posting. This range may bemodifiedin the future. 

This job is also eligible for bonus/incentive pay. 

We offercomprehensivepackage of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. 

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Companys sole discretion, consistent with the law. 

Bonus / Incentive Pay

10% of annual base salary 

This job is also eligible for bonus / incentive pay.This is the target earnings as % of base annual salary, subject to objective eligibility criteria and performance conditions as set out in the applicable scheme terms and conditions. 

This job is also eligible for a comprehensive package of benefits. Detailsregardingthese benefits will be provided separately.