Sr. Regulatory Affairs Specialist

Join our mission-driven Regulatory Affairs team as the Sr. Regulatory Affairs Specialist at Endologix! WHO WE ARE: 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 trainingsupported by industry-leading clinical evidence. At Endologix, were driven by purpose, innovation, and the opportunity to make a lasting impact in vascular health. What sets us apart is not just our technology, but our culture. At Endologix, we foster a forward-thinking, mission-driven environment where every team member plays a vital role in advancing patient care. Our core values guide how we operate. As for our people? We empower them with the tools, trust, and continuous learning they need to grow. If youre passionate about making a meaningful difference in healthcare, youll find purpose and belonging here. Our Core Values: Our values are the guiding principles informing our choices and actions, because our customers and patients depend on us: - Patient Outcomes Drive Us: We improve lives with every advancement we deliver. - Integrity Defines Us: We do whats 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. ABOUT THE ROLE: Were looking for a Sr. Regulatory Affairs Specialist to join our mission-driven Regulatory Affairs team. In this role, youll 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. WHAT YOU'LL DO: 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 regu atory 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 Endologixs 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 of changing regulations on submission strategies and communicate implications clearly and proactively to relevant stakeholders. Track applications under regulatory review and communicate status, risks, and timelines transparently to cross-functional partners. Monitor and submit required regulatory reports, ensuring accurate, timely responses that reflect ownership and accountability. Evaluate proposed preclinical, clinical, design, and manufacturing changes to determine appropriate regulatory filing strategies that balance compliance with innovation. Negotiate and interact with regulatory authorities during development and review processes with professional integrity to facilitate submission approvals. Provide strategic regulatory input and technical guidance to development teams, enabling informed decision-making and cross-functional alignment. Review proposed post-market changes to determine regulatory impact and required submission pathways, ensuring continued compliance and product availability. Maintain and update Technical Files and Design Dossiers to support product continuity and regulatory readiness. Oversee regulatory processes related to annual licenses, registrations, listings, and patent information to ensure sustained market compliance. Ensure ongoing compliance wit