Sr. Regulatory Affairs Specialist

Overview

Join our mission-driven Regulatory Affairs team as the Sr. Regulatory Affairs Specialist at Endologix!

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. Our therapeutic portfolio addresses clinically relevant unmet needs, spanning from abdominal aortic aneurysms to lower limb peripheral vascular disease. We are committed to delivering excellent clinical outcomes through precision in product design, advanced manufacturing, and comprehensive physician training—supported by industry-leading clinical evidence.

At Endologix, we’re driven by purpose, innovation, and the opportunity to make a lasting impact in vascular health. Our core values guide how we operate. We empower our people with the tools, trust, and continuous learning they need to grow. If you’re passionate about making a meaningful difference in healthcare, you’ll find purpose and belonging here.

• Patient Outcomes Drive Us:
  We improve lives with every advancement we deliver.
• Integrity Defines Us:
  We do what’s right, stay transparent, prioritize quality, and own our actions.
• Innovation Advances Us:
  We stay curious, adaptable, and push boundaries.
• Boldness Propels Us:
  We take smart risks and are unafraid in our pursuit of excellence.
• Collaboration Unites Us:
  We partner across teams and with physicians to drive exceptional results.

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.

• 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.
• Leverage advanced technical and regulatory expertise to propose bold, well-reasoned strategies that resolve complex regulatory challenges while maintaining compliance.
• Determine, interpret, and support fulfillment of submission and approval requirements with transparency, accountability, and attention to detail.
• Review analytical and clinical protocols to ensure appropriate data collection that supports robust regulatory submissions and protects patient outcomes.
• Participate in cross-functional risk management activities, contributing regulatory insight to proactively mitigate potential patient, product, and compliance risks.
• Stay current on new and revised regulations, guidances, and industry trends, evaluating impact and driving informed, forward-looking regulatory decisions.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and collaborate across teams to develop effective, compliant solutions.
• Serve as a core regulatory team member, providing sustained regulatory leadership and partnership to cross-functional project teams.
• Assess the acceptability of quality, preclinical, and clinical documentation to ensure submissions meet regulatory expectations and uphold Endologix’s quality standards.
• Compile, prepare, review, and submit regulatory submissions to global regulatory authorities; interact with authorities professionally and responsively to support timely approvals.
• Build and strengthen relationships with senior internal and external stakeholders through effective communication, collaboration, and influence, adapting messaging to diverse audiences and advising on complex regulatory matters.
• Monitor the impact…