Clinical Complaint Specialist

Danaher•Irvine, CA

1d•Onsite

About The Position

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.

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.

Nice To Haves

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.

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.