Manager, Global Product Surveillance

The Manager, Global Product Surveillance is responsible for supporting the strategic planning, development, and oversight of Glaukos' global product surveillance functions including complaint, adverse event, and customer feedback processing. The Manager, Global Product Surveillance leads a team that monitors product safety and performance, ensuring compliance with global regulations.

This position plays a pivotal role in early signal detection by applying medical and clinical expertise in ensuring high quality assessment of all global safety events to determine the real or potential impact of product performance issues on patient safety.

This role interfaces externally with customers and requires cross-functional collaboration with Quality, Regulatory, Clinical, R&D, and Commercial teams to ensure timely and accurate reporting of complaints and adverse events.

What Will You Do

Post Market Product Surveillance

• Oversee intake, assessment, investigation, and reporting of adverse events, and complaints in accordance with internal procedures and global regulatory requirements
• Escalate events or findings that may warrant triage escalation, health hazard evaluation, or corrective and preventative action
• Maintain knowledge of global regulations and standards related to pharmacovigilance and medical device vigilance
• Support signal detection, trend analysis, and risk assessment using data from complaints, adverse events, and customer feedback
• Collaborate with cross-functional teams to ensure effective root cause analysis

Management

• Lead and manage Global Product Surveillance team responsible for medical device and combination product complaint and adverse event processing
• Ensure compliance with internal procedures and global regulations. Recommend updates to processes and procedures as needed
• Training, development, and onboarding of team members
• Identify and help drive continuous improvement initiatives within the product surveillance system to enhance compliance and operational efficiency
• Ensure adherence to department metrics and objectives

Safety/Risk

• Apply clinical knowledge to ensure appropriate and adequate follow up on complaints and adverse events
• Provide medical and clinical expertise in assessment of real or potential impacts of product performance issues and adverse incidents for all product lines
• Oversee documentation and approvals of assessments/evaluations of customer complaints as required per each region's regulatory requirements and supporting clinical rationales; ensuring all complaint documentation meets Good Documentation Practices

How Will You Get Here

• Bachelor's degree in Life Sciences, Pharmacy, Engineering, Nursing, or related field required.
• 8+ years of relevant industry experience
• 1+ years in a leadership or managerial role
• Knowledge of ophthalmology preferred
• Knowledge of global regulatory requirements and standards, including FDA, EU MDR, ISO 13485, TGA, Health Canada
• Strong leadership, communication, and interpersonal skills
• Excellent analytical, problem-solving, and decision-making abilities
• Detail-oriented with a high degree of accuracy and compliance focus
• Ability to work effectively in a global, cross-functional environment
• Proficient in Microsoft Office and complaint management systems