Clinical Complaint Specialist
Masimo · Irvine, CA · 2 wk ago
On-siteHealthcare$80k–$100k/yrFull-time
Duties & 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.
- 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.
- Afford assistance 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.
- 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.
- 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.
- Medical
- Dental
- Vision
- Life/AD&D
- Disability Insurance
- 401(k)
- Vacation
- Sick
- Holiday
- Paid Maternity Leave
- Flexible Spending Accounts
- Voluntary Accident
- Critical Illness
- Hospital
- Long-Term Care
- Employee Assistance Program
- Pet Insurance
- On-site wellness clinic
- Fitness center
- Cafe
- 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.
- This position primarily works in an office environment and requires frequent sitting, standing, and walking.
- Daily use of a computer and other digital devices is required.
- This role may require standing for extended periods when facilitating meetings or walking through facilities.
Minimum Qualifications
Preferred Qualifications
Compensation
The anticipated salary range for this position is $80,000 - $100,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.