Sr. Product Surveillance Specialist II

23 hours ago

Aliso Viejo, California, United States Glaukos Full time

The Senior Product Surveillance Specialist II serves as a key leader within the global Post-Market Surveillance (PMS) program at Glaukos, ensuring compliance with worldwide medical device and pharmaceutical regulations. This individual will independently lead global surveillance activities, monitor product performance, identify safety trends, and ensure timely and accurate regulatory reporting across multiple markets.

Key Responsibilities

  • 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.

Qualifications

  • Bachelor's degree in life sciences, engineering, pharmacy, or related field; advanced degree preferred.
  • 8+ years of experience in post-market surveillance, regulatory, or quality within medical device or pharma.
  • Strong working knowledge of EU MDR, FDA 21 CFR Part 803, ISO 13485, and ICH guidelines.
  • Proven experience preparing PMSRs/PSURs and managing global vigilance reporting.
  • Excellent analytical, communication, and organizational skills.
  • Experience supporting regulatory inspections and audits.
  • Familiarity with electronic complaint handling and reporting systems.
GKOSUS

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