Report

Product Surveillance Specialist I

Salary

$82k - $107k

Min Experience

0 years

Location

Aliso Viejo, California, United States

JobType

full-time

About the job

Info This job is sourced from a job board

Overview

About the role

Product Surveillance Specialist I

Location: Aliso Viejo, CA

Make an impact in patient safety and product quality.

The Product Surveillance Specialist I supports post-market safety and compliance activities, including complaint handling and Medical Device Reporting (MDR) / Vigilance processes. This role ensures timely, accurate, and compliant reporting of adverse events while helping improve processes that enhance patient outcomes and product safety.

What Will You Do

Assist in complaint management and MDR/Vigilance reporting to ensure compliance with global regulatory requirements.
Support complaint investigations from initiation to closure, ensuring accuracy, documentation, and proper risk assessment.
Review complaint coding and evaluation reports; draft customer letters summarizing findings.
Participate in trend analysis and generate reports for management reviews.
Contribute to process development, CAPA initiatives, and employee training on complaint handling and MDR regulations.

How Will You Get Here

Education: Bachelor’s degree in Nursing or other health-related discipline (RN, pharmacist, risk manager, or biomedical engineer).
Experience: 0–2 years in clinical, pharmaceutical, or medical device industries, with at least 1 year in complaints/MDR/adverse event reporting.
Knowledge of FDA (21 CFR 803, 806, 820), ISO 13485/14971, EU MDR, Health Canada, and other international regulations.
Strong analytical, communication, and organizational skills.
Ability to manage timelines, work cross-functionally, and train others on regulatory processes.
Ophthalmology experience preferred.

#GKOSUS

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.

About the company

Glaukos Corporation operates as an ophthalmic medical technology company. The Company develops, manufactures, and markets medical devices for the treatment of glaucoma. Glaukos offers micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression.

Skills

compliance

cross-functionally