Sr. Clinical Field Assurance Specialist

Overview

Join our mission-driven Field Assurance department as a Sr. Clinical Field Assurance 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 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.

 

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 you’re passionate about making a meaningful difference in healthcare, you’ll find purpose and belonging here.

Our Core 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 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.

 

ABOUT THE ROLE:

 

The Sr. Clinical Field Assurance Specialist is responsible for providing clinical/medical insight and guidance into the customer complaint handling process for the purpose of ensuring compliance with US and international regulatory compliance and complaint handling/device reporting requirements.  This position also is responsible for the timely completion of assigned activities related to regulatory compliance support activities worldwide.

Responsibilities

WHAT YOU'LL DO:

• Review, analyze, and synthesize medical records and imaging (e.g., CT scans) to support accurate, high-quality investigational reports for customer complaints, with a clear focus on improving patient outcomes.
• Conduct thorough clinical evaluations to objectively identify and confirm both reported and unreported device failure modes, ensuring a high standard of quality and accountability.
• Document clinical findings in department systems with precision and transparency, maintaining full compliance with quality and regulatory requirements.
• Support adjudication activities, including report development and meeting preparation, enabling clear, data-driven decision-making.
• Contribute to Medical Device Reporting (MDR), vigilance, and global regulatory processes, ensuring timely, compliant, and reliable reporting.
• Partner closely with the Patient Safety Director and cross-functional stakeholders to address adverse event inquiries and drive aligned, effective resolutions.
• Deliver clinical and technical training to Field Assurance team members, promoting consistency, knowledge-sharing, and team growth.
• Support interactions with regulatory bodies and contribute to complex case evaluations with sound judgment and confidence.
• Apply critical thinking and adaptability to support labeling updates, risk management activities, quality systems, audits, and continuous improvement efforts.
• Assist the Principal Clinical Field Assurance Specialist and department leadership on strategic initiatives and evolving business priorities.

Qualifications

WHAT YOU'LL BRING:

 

Education:

• Registered Nurse (RN) highly preferred or LVN with a combination of working experience.

Experience:

• 5+ years of medical device experience (Class II/III) or a combination of clinical and medical device
• Some knowledge with regulatory reporting, quality systems and relationship to business.

Skills/Competencies:

• Interpersonal Effectiveness & Influence: Builds strong, trust-based relationships across