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Product Surveillance Specialist I at Glaukos Corporation
Aliso Viejo, California, United States -
Full Time

Start Date

Immediate

Expiry Date

07 Jan, 26

Salary

0.0

Posted On

09 Oct, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Complaint Management, MDR Reporting, Adverse Event Reporting, Regulatory Compliance, Risk Assessment, Trend Analysis, Process Development, CAPA Initiatives, Employee Training, Analytical Skills, Communication Skills, Organizational Skills, Ophthalmology Experience

Industry

Medical Equipment Manufacturing

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