Sr. Clinical Field Assurance Specialist

Endologix

4d•$95,000 - $110,000•Hybrid

About The Position

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.

Requirements

Registered Nurse (RN) highly preferred or LVN with a combination of working 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.
Interpersonal Effectiveness & Influence: Builds strong, trust-based relationships across all levels by actively seeking to understand diverse perspectives and navigating interactions with professionalism, diplomacy, and emotional intelligence. Demonstrates self-awareness, adapts communication style as needed, and resolves conflict constructively.
Communication & Technical Writing: Communicates clearly and effectively across all mediums, from group presentations to one-on-one discussions. Demonstrates strong technical writing skills, including the ability to develop reports, procedures, and documentation that are clear, accurate, and actionable. Actively listens and continuously refines communication approach to enhance impact.
Collaboration & Cross-Functional Partnership: Works seamlessly across teams, functions, and with external partners to achieve shared goals. Fosters alignment, encourages open dialogue, and contributes to a collaborative environment that drives high-quality outcomes.
Leadership & Investigational Facilitation: Provides leadership and direction in investigational activities, ensuring structured, thorough, and timely execution. Guides teams through complex technical challenges with a focus on sound judgment, accountability, and continuous learning.
Prioritization & Execution: Effectively manages multiple priorities in fast-paced, technically complex environments. Demonstrates strong organizational skills, sound judgment, and the ability to independently prioritize and deliver high-quality work within established timelines.
Accountability & Ownership: Takes initiative and ownership of responsibilities, consistently delivering results while maintaining a high standard of quality and integrity. Proactively identifies needs, follows through on commitments, and supports broader organizational objectives.
Technical Expertise & Continuous Learning: Builds and applies functional and technical expertise with increasing scope and complexity. Remains curious, adaptable, and committed to learning, leveraging new tools, technologies, and best practices to enhance performance.
Problem Solving & Critical Thinking: Applies strong analytical and applied thinking skills to identify root causes, solve complex problems, and implement sustainable solutions. Anticipates challenges and emphasizes prevention through thoughtful planning and continuous improvement.
Continuous Improvement Mindset: Utilizes structured methodologies and best practices to identify opportunities for improvement, enhance processes, and build new capabilities. Embraces change and drives innovation in pursuit of better outcomes.
Global & Systems Thinking: Understands and navigates cross-functional and global interdependencies, considering the broader impact of decisions. Aligns work with organizational priorities while respecting diverse perspectives and operating environments.
Computer & Technical Proficiency: Proficient in Microsoft Office Suite and relevant charting/programming tools; able to effectively leverage technology to analyze data, create reports, and support business needs.
Language & Communication Skills: Ability to read, analyze, and interpret professional journals, technical procedures, legal documents, and regulations. Capable of producing clear business correspondence and presenting information effectively to varied audiences.
Mathematical & Analytical Skills: Applies mathematical concepts such as probability, statistical inference, percentages, ratios, and proportions to practical business and technical situations.
Reasoning Ability: Solves practical problems in dynamic environments with limited standardization. Interprets and executes instructions across written, oral, diagrammatic, and schedule-based formats.
Equipment & Tools: Proficient in the use of standard business and office equipment, including computers and related technologies.

Responsibilities

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.

Benefits

Base salary of $95,000/yr-$110,000/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
Commuter benefits or transportation stipends