Clinical Complaint Specialist

Masimo•Irvine, CA

8h•$80,000 - $100,000•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. The Clinical Complaint Specialist partners cross-functionally to support complaint handling, post-market surveillance, and continuous improvement initiatives.

Requirements

Registered Nurse (RN), Bachelor of Science in Nursing (BSN), or equivalent clinical degree.
Minimum three (3) years of clinical nursing or direct patient care experience.
Strong clinical assessment and critical thinking skills.
Ability to interpret medical records, clinical documentation, and adverse event information.
Strong written, verbal, and interpersonal communication skills.
Strong attention to detail and organizational skills.
Proficiency with Microsoft Office applications.
Ability to read, write, and communicate effectively in English.
Ability to interpret technical documents, schematics, and written instructions.
Ability to clearly document technical findings and communicate with cross-functional team members.

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.
Experience using electronic quality management systems (eQMS) or complaint management systems.
Advanced clinical degree or specialty certification.

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.
Classify and code complaint events using established coding systems and internal procedures.
Review complaint records for completeness and obtain additional information as necessary to support complaint evaluations and investigations.
Document complaint assessments, reportability determinations, and supporting rationale within complaint management systems.
Support the preparation, review, and submission of adverse event reports to regulatory authorities as required.
Collaborate with Quality, Regulatory Affairs, Medical Affairs, Clinical Affairs, Engineering, Manufacturing, and other cross-functional teams to support complaint investigations and resolution activities.
Identify and escalate potential product safety concerns, emerging risks, and quality issues.
Participate in post-market surveillance activities, including complaint trending, signal detection, and risk assessments.
Support internal audits, regulatory inspections, and quality system assessments related to complaint handling processes.
Assist with the development, maintenance, and continuous improvement of complaint handling procedures, work instructions, and quality system documentation.
Maintain current knowledge of applicable regulations, standards, and industry best practices related to complaint handling and post-market surveillance.
Perform other duties as assigned.