Join our Regulatory Affairs team as a Regulatory Affairs Specialist at Endologix! We're looking for a Regulatory Affairs Specialist to support, develop, and drive the timely preparation of regulatory submissions and product updates necessary to obtain and maintain regulatory approvals for Endologix products.
Requirements
- Support and maintain regulatory processes and SOPs with integrity and transparency, ensuring ongoing compliance with current and evolving regulations while prioritizing quality and patient safety in alignment with Endologix’s commitment to improving patient outcomes.
- Develop and update multi-country regulatory strategies in response to regulatory and product changes, applying innovative and adaptable thinking to support timely patient access to therapies.
- Review analytical and clinical protocols to ensure the collection of robust, high-quality data that supports sound regulatory submissions and advances patient-focused decision-making.
- Anticipate regulatory obstacles and emerging issues across the product lifecycle, taking bold yet informed action and partnering cross-functionally to develop effective, compliant solutions.
- Serve as a regulatory core team member, collaborating closely with project teams to deliver regulatory guidance that supports timely innovation and exceptional patient outcomes.
Benefits
- Base salary of $90,000/yr-$102,500/yr
- Discretionary bonus
- Equity participation as approved by Board of Directors (4-year vesting schedule)
- 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
- Flexible work arrangements, such as hybrid or remote work for many of our positions
- Employee wellness initiatives, mental health resources, and Employee Assistance Program (EAP)
- Employee recognition programs and awards
- Learning and development opportunities
- Commuter benefits or transportation stipends
- Company events and team-building activities