Clinical Complaint Specialist

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

Benefits offered by this job

Medical/dental/vision insurance

401(k)

Paid time off

Job summary

Masimo, a global medical technology leader, is seeking a Clinical Complaint Specialist to assess and process medical device complaints in support of regulatory compliance and product safety. This on-site role is based in Irvine, CA and reports to the Director, Quality Customer Complaints.

You will apply clinical expertise to evaluate events, determine patient impact, and support investigations while ensuring accurate documentation.

Qualifications

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

Responsibilities

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

Skills

Clinical nursing

Clinical documentation

Adverse event assessment

Education

RN or BSN or equivalent clinical degree

Job description

About the Role

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Masimo, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Masimo is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including non-invasive measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is, Masimo innovations empower clinicians to transform patient care. When you join our team, you’ll be part of a culture that’s driven by passion, challenging the status quo, and making an impact in the lives of others. Learn about the Danaher Business System which makes everything possible.

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.

Location & Reporting

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.

Key Responsibilities

• 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.

Essential Requirements

• 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.

Preferred Experience

• 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.

Benefits

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

Details regarding these benefits will be provided separately.

Pay

The annual salary range for this role is $80,000 - $100,000. This range may be modified in the future. This job is also eligible for bonus/incentive pay. Bonus / Incentive Pay 10% of annual base salary. This job is also eligible for a comprehensive package of benefits.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities.

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.