Product Surveillance Specialist II

Product Surveillance Specialist II

Location: Aliso Viejo, CA

Global Product Surveillance Specialist

The Global Product Surveillance Specialist plays a critical role in ensuring the post-market safety and effectiveness of all Glaukos products. This position is responsible for investigating and evaluating global complaints and adverse events, performing preliminary assessments for regulatory reportability, and supporting continuous safety surveillance activities. The role requires close collaboration with cross-functional teams to identify root causes, ensure timely and accurate reporting, and maintain compliance with international regulatory standards.

Key Responsibilities:

• Evaluate post-market product events to determine complaint or adverse event classification and investigation requirements
• Conduct and coordinate complaint investigations in accordance with SOPs and global regulations
• Perform preliminary reportability assessments for events across multiple regions (US, Canada, EU, Australia, etc.)
• Support risk management activities by reviewing complaints against product-specific risk documents
• Coordinate with internal and external partners, including manufacturers, to ensure accurate investigation outcomes
• Review documentation for completeness and accuracy, driving timely closure of complaints
• Maintain current knowledge of Glaukos products and applicable global regulations
• Provide support during internal and external audits and contribute to ongoing safety surveillance

Qualifications:

• Bachelor's degree (preferably in Life Sciences) or equivalent experience
• Minimum 3 years of relevant experience in the clinical, pharmaceutical, or medical device industry
• Experience in Regulatory Affairs or Quality Assurance; complaint handling preferred
• Knowledge of regulations and standards including ISO 13485/14971, 21 CFR (803, 806, 820), EU MDR, Health Canada, IRIS, and MDSAP
• Strong communication skills and ability to work effectively with cross-functional teams
• Experience with combination products or drug-device interactions preferred