Regulatory Affairs Specialist II

Glaukos Corporation
United States, California, San Clemente
Dec 29, 2024
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