Regulatory Affairs Specialist II

Job Description
GLAUKOS - REGULATORY AFFAIRS SPECIALIST II

How will you make an impact?

The Regulatory Affairs Specialist II is responsible for preparation of international regulatory submissions. Ensure implementation and maintenance of regulatory filing in compliance with applicable regulations and Glaukos internal SOPs. This individual will review international regulatory requirements and compile submissions accordingly.

What will you do?

• Knowledge of Regulations for US, EU, Canada, and others
• Independently compile and submit accurate, appropriate documentation
• Compile materials required for submissions, license renewals, and annual registrations
• Evaluate changing international regulatory requirements, assessing and reporting on impact
• Prepare and maintain required materials including but not limited to:

• FDA export certificates (CFG) requests
• Document legalization
• License renewals (including state licenses)
• Country approval list
• Other regularly maintained registrations and licenses

Review of labeling, advertising, and document change orders as needed

Coordinate and respond to information requests from international regulatory agencies

Research scientific and regulatory information in order to write, edit, and review reports

Work with state and governmental regulatory agencies as required

Maintain regulatory files and associated spreadsheets, reports, documents, including periodic reviews

Assist team members with internal audits, customer audits, and third-party audits, including those by US and international regulatory agencies

Assist with other basic Regulatory Affairs functions, such as scanning and archiving records

Other Duties

• Participate in company training programs that maintain appropriate awareness and compliance
• May perform other duties as assigned, such as US filings, development, and participation

How will you get here?

• BS degree required.
• 2+ years of related regulatory or quality experience
• Takes ownership of assigned projects and duties, seeing through to completion
• Proactively seeks opportunities for contribution or improvement
• Critical thinking, able to perform root cause analysis and generate multiple potential solutions
• Effective verbal communication and clear, concise writing skills
• Well organized, self-motivated and dependable
• Open to directions and constructive feedback
• Adaptable and able thrive in an entrepreneurial, highly collaborative environment

About Us
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.