Irvine, California, United States · On-site
$80k–$100k/yr
Job 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 ro…
Skills: Clinical Assessment, Complaint Handling, Regulatory Compliance, Medical Device Reporting, Post-Market Surveillance
Irvine, California, United States · Hybrid
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Skills: Procurement, Vendor Management, Budgeting, Compliance, Organization
Irvine, California, United States · Hybrid
$142k–$269k/yr
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Skills: CDISC Standards, SDTM, CDASH, ADaM, Define.xml
Irvine, California, United States · Hybrid
Benefits: Company parties Competitive salary Flexible schedule Wellness resources Job Summary Orange County Health Psychologists seeks an experienced Psychiatrist to join our thriving, highly-regarded group practice of 7…
Skills: Psychiatric Evaluation, Medication Management, Diagnosis, Treatment Planning, Patient-Centric Care
Irvine, California, United States · On-site
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Skills: AI/ML, Data Science, Software Engineering, Python, LLM
Irvine, California, United States · Remote OK
$165k–$231k/yr
Hi Tarsan! Thanks for your interest in this position. Please review the details and if role and if it's something that could match your career goals, connect with your current manager and HRBP to discuss if your experien…
Skills: Medical Strategy, Medical Education, KOL Engagement, Insight Collection, Project Management
Irvine, California, United States · Remote OK
$165k–$231k/yr
About the Role The Associate Director, Medical Strategy & Education serves as a key partner within Medical Affairs, supporting the development and delivery of medical education, KOL consulting engagement, and structured …
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Irvine, California, United States · On-site
$191k–$271k/yr
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Skills: Clinical Safety Strategy, People Management, Risk Mitigation, Regulatory Compliance, Clinical Trial Safety
Irvine, California, United States · On-site
$98k–$144k/yr
About Marvell Marvell’s semiconductor solutions are the essential building blocks of the data infrastructure that connects our world. Across enterprise, cloud and AI, and carrier architectures, our innovative technology …
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Irvine, California, United States · On-site
$121k–$171k/yr
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Skills: Electrical Hardware Design, RF Devices, Project Management, People Management, Design Control
Irvine, California, United States · On-site
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Irvine, California, United States · On-site
$162k–$240k/yr
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Skills: NPI, ATE Test Systems, PMIC Testing, Advantest V93000, Java
Irvine, California, United States · On-site
Job Summary: Zymo Research is looking for a dynamic individual to join our Microbiomics team. This is an exciting opportunity to explore the impact of cutting-edge methods, technologies, and applications in molecular mic…
Skills: Molecular Biology, Experimental Design, Genetic Engineering, Recombinant Gene Design, Data Collection
Irvine, California, United States · On-site
About Rivian Rivian is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract. As a company, we con…
Skills: Computational Fluid Dynamics, Aerodynamics, Python, Matlab, Catia V6
Irvine, California, United States · On-site
Summary: ATI is currently looking for a Metallurgical Engineer (Engineer II) at our Irvine, CA location. The Metallurgical Engineer is responsible for developing materials application, forged product and manufacturing re…
Skills: Metallurgical Engineering, Materials Science, Analytical Skills, Problem-solving, Microsoft Office
Irvine, California, United States · On-site
Company Description We provide Recruitment and Staffing services to many industries and domain through our innovative and customized solutions and passionate commitment to research. Ability to understand the hiring strat…
Skills: AI/ML, Data Science, Software Engineering, Python, LLM
Irvine, California, United States · On-site
$150k–$280k/yr
At Turion Space, understanding the mission space is what turns advanced technology into operational capability. As the Director of Mission Engineering, you'll lead the modeling and simulation efforts that frame how our s…
Skills: Mission Engineering, Systems Engineering, Modeling And Simulation, Design Reference Missions (DRMs), System Trade Studies
Irvine, California, United States · Hybrid
$102k–$160k/yr
Employment Type: Salaried Work Arrangement: Remote Position Summary: The Manager of Food Safety Compliance and Culture provides proactive leadership in developing, implementing, and monitoring company's food safety cultu…
Skills: Food Safety Compliance, Internal Auditing, GFSI, FSMA, HACCP
Irvine, California, United States · Hybrid
$40/hr–$80/hr
Acute Care TechnologyDevelops, documents, executes, and maintains software verification procedures, software testing tools, and associate tracing to support development of ZOLL products in accordance with regulatory requ…
Skills: Software Verification, Embedded Software Testing, Medical Device Software Development, SDLC Tools, Bug Tracking
Irvine, California, United States · On-site
$150k–$270k/yr
At Turion Space, our astronautical engineering work is what makes autonomous operations in orbit possible. This team owns the flight dynamics, navigation, guidance, and mission analysis that let our spacecraft maneuver, …
Skills: Astronautical Engineering, Flight Dynamics, Navigation, Guidance, Mission Analysis
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The Clinical Complaint Specialist performs clinical assessments and evaluations of medical device complaints to ensure regulatory compliance and product safety. This role involves determining regulatory reportability, supporting investigations, and collaborating cross-functionally to manage post-market surveillance.
Candidates must be a Registered Nurse (RN) or hold a BSN with at least three years of clinical nursing or direct patient care experience. Proficiency in interpreting medical records and knowledge of FDA reporting requirements are highly preferred.
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.
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.
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.
Masimo offers benefits such as 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, and cafe. All benefits are subject to eligibility requirements.
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.
The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.
Masimo is proud to be an EEOE/, M/F/D/V, and we are committed to Diversity at the corporate level.
Masimo innovations empower clinicians to transform patient care.
Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve life, improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown to outperform other pulse oximetry technologies in over 100 independent and objective studies, which can be found at www.masimo.com/evidence/featured-studies/feature. Masimo SET® is estimated to be used on more than 200 million patients around the world each year and is the primary pulse oximetry at all 10 top U.S. hospitals as ranked in the 2025 Newsweek World’s Best Hospitals listing. Additional information about Masimo and its products may be found at www.masimo.com.
Offices: 52 Discovery, Irvine, CA 92618, US
There are currently 497 open science & research positions in Irvine, CA listed on Clera. New openings are added daily as companies post roles.
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