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Glaukos Corporation · 2 months ago

Sr. Product Surveillance Specialist II

Aliso Viejo, CA

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Glaukos Corporation is a leader in the medical device industry, and they are seeking a Senior Product Surveillance Specialist II to lead their global Post-Market Surveillance program. This role involves ensuring compliance with medical device regulations, monitoring product performance, and overseeing regulatory reporting across various markets.

Health CareMedicalWellness

Growth Opportunities

H1B Sponsor Likely

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

Qualification

Post-market surveillanceRegulatory complianceEU MDR knowledgeFDA regulationsISO 13485 knowledgeRegulatory inspections supportAnalytical skillsElectronic complaint handlingCommunication skillsOrganizational skills

Required

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

Glaukos Corporation

At Glaukos, our focus is to develop and lead the global ophthalmic market with novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases—therapies that advance the existing standard of care and enrich the lives and treatment alternatives for patients worldwide.

Founded in 1998

San Clemente, California, USA

1001-5000 employees

http://www.glaukos.com

H1B Sponsorship

Glaukos Corporation has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (5)

2024 (6)

2023 (1)

2022 (3)

2021 (1)

Funding

Current Stage

Public Company

Total Funding

$121M

Key Investors

Meritech Capital PartnersOrbiMed

2015-06-25IPO

2013-02-07Series F· $30M

2012-10-03Debt Financing· $6M

Leadership Team

Alex Thurman

Senior Vice President and Chief Financial Officer

Joseph Gilliam

President & Chief Operating Officer

Recent News

Orange County Business Journal

Midday Stock Roundup: Shimmick Drops on Low Volume

2026-01-24

Orange County Business Journal

Do Not Use

2026-01-22

BioSpace

Glaukos Announces Preliminary, Unaudited Fourth Quarter and Full Year 2025 Net Sales and Reaffirms 2026 Revenue Guidance

2026-01-16

Company data provided by crunchbase