Endologix LLC is a California-based global medical device company dedicated to improving patients’ lives through innovative therapies for the interventional treatment of vascular disease. We're looking for an Associate Regulatory Affairs Specialist - International to join our mission-driven Regulatory Affairs team.
Requirements
- Support and maintain international regulatory processes and SOPs with a strong commitment to integrity, ensuring ongoing compliance with current and evolving regulations and prioritizing quality and patient safety.
- Stay current on new and revised international regulations, guidance, and industry publications, proactively assessing impact and applying insights to support patient-focused regulatory decisions.
- Compile, prepare, review, and submit high quality regulatory filings to international health authorities accurately and efficiently, demonstrating accountability and ownership.
- Build and maintain effective working relationships internally, collaborating across teams and exchanging information with colleagues, project leaders, and supervisors to support shared objectives.
- Collaborate on EU local registrations and tender requests to ensure accuracy and submission on a timely basis.
- Track applications under international regulatory review and provide transparent updates to internal teams.
- Evaluate proposed preclinical, clinical, design, and manufacturing changes, applying sound judgment and adaptable thinking to develop and implement appropriate international regulatory filing strategies in conjunction with the RA product owner.
- Review proposed post-market changes to assess international regulatory impact and required submissions, ensuring continued compliance and product availability for patients.
- Assist with the processing of Certificate to Foreign Government or Export Certificate for Global registration as required.
- Support regulatory processes related to annual licenses, registrations, listings, and patent information to maintain market access and compliance.
Benefits
- Comprehensive health, dental, and vision insurance plans
- Flexible Health Savings Accounts (HSAs) and/or Flexible Spending Accounts (FSAs)
- Generous paid time off (vacation, sick leave, holidays, and flexible time off that is available for Exempt employees)
- 401(k) retirement plan with company match
- Employee wellness initiatives, mental health resources, and Employee Assistance Program (EAP)
- Employee recognition programs and awards
- Commuter benefits or transportation stipends
