Sr. Regulatory Affairs Specialist

About the Role

We’re looking for a Sr. Regulatory Affairs Specialist to join our mission-driven Regulatory Affairs team. In this role, you’ll support, develop, and drive the timely preparation of regulatory submissions and product updates necessary to obtain and maintain regulatory approvals for Endologix products. This position will support the regulatory strategy, review of design changes, manufacturing changes and specification changes.

Responsibilities

• Develop, implement, and maintain regulatory processes and SOPs with a strong commitment to Integrity, ensuring compliance with current and evolving global regulations and prioritizing product quality and patient safety.
• Provide regulatory leadership and input to product lifecycle planning to support patient outcomes and enable timely access to life-improving therapies.
• Assist in the development and execution of multi-country regulatory strategies (U.S., EU, and Canada), applying innovative and adaptable approaches to evolving regulatory and product requirements.