Sr. Product Surveillance Specialist II at Glaukos Corporation
Glaukos Corporation · Aliso Viejo, United States Of America · Onsite
- Senior
- Office in Aliso Viejo
- 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.
- 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.
Company
Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible.
Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases.
Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients.
Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra “We’ll Go First,” which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.
Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol “GKOS”. Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.
Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.
