Product Surveillance Specialist I

Product Surveillance Specialist I

Location: Aliso Viejo, CA

Make an impact in patient safety and product quality.

The Product Surveillance Specialist I supports post-market safety and compliance activities, including complaint handling and Medical Device Reporting (MDR) / Vigilance processes. This role ensures timely, accurate, and compliant reporting of adverse events while helping improve processes that enhance patient outcomes and product safety.

What Will You Do

• Assist in complaint management and MDR/Vigilance reporting to ensure compliance with global regulatory requirements.
• Support complaint investigations from initiation to closure, ensuring accuracy, documentation, and proper risk assessment.
• Review complaint coding and evaluation reports; draft customer letters summarizing findings.
• Participate in trend analysis and generate reports for management reviews.
• Contribute to process development, CAPA initiatives, and employee training on complaint handling and MDR regulations.

How Will You Get Here

• Education: Bachelor's degree in Nursing or other health-related discipline (RN, pharmacist, risk manager, or biomedical engineer).
• Experience: 0-2 years in clinical, pharmaceutical, or medical device industries, with at least 1 year in complaints/MDR/adverse event reporting.
• Knowledge of FDA (21 CFR 803, 806, 820), ISO 13485/14971, EU MDR, Health Canada, and other international regulations.
• Strong analytical, communication, and organizational skills.
• Ability to manage timelines, work cross-functionally, and train others on regulatory processes.
• Ophthalmology experience preferred.