Glaukos Corporation
Product Surveillance Specialist II
Glaukos Corporation, Aliso Viejo, California, United States, 92656
Overview
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 combining products or drug-device interactions preferred
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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 combining products or drug-device interactions preferred
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