Sr. Product Surveillance Specialist II

The Senior Product Surveillance Specialist II is a key leader within the global Post-Market Surveillance (PMS) program at Glaukos, ensuring compliance with worldwide medical device and pharmaceutical regulations.

Requirements

• Lead global PMS activities, including annual reviews and preparation of PMSRs, PSURs, Trend Reports, and related regulatory submissions.
• Oversee global Medical Device and Vigilance reporting to ensure compliance with FDA, EU MDR, Health Canada, and other international standards.
• Collaborate cross-functionally with Regulatory, Quality, and Medical Safety teams to ensure comprehensive reporting and inspection readiness.
• Analyze complaint and field data to identify trends and recommend risk mitigation actions.
• Maintain and update PMS procedures to align with evolving global regulations and best practices.
• Provide guidance and mentorship to junior team members while operating as an independent subject matter expert.

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance