Clinical Complaint Specialist
Danaher Corporation
Summary
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.
Job description
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.
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
- 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
- Health care program
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- Bonus/incentive pay
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.