Staff Auditor, Regulatory

Overview

Join our innovative, mission-driven Quality team as a Staff Auditor, Regulatory 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 Staff Auditor, Regulatory is a senior individual contributor responsible for leading the execution and continued maturation of the company’s risk-based internal audit program, coordinating external audit and inspection readiness, and translating emerging regulatory requirements into actionable Quality System insight. Reporting to the Director, Audit, Supplier Quality & Applied AI Architecture, this role manages the enterprise audit schedule, leads complex Quality Management System audits, supports regulatory and certification audits from preparation through response and lessons learned, and publishes a concise monthly regulatory intelligence newsletter. The role also partners with the Director and cross-functional stakeholders to design, test, govern, and improve human-in-the-loop AI agents supporting audit planning, readiness, evidence review, regulatory intelligence, and risk detection. The Principal Auditor serves as a trusted subject matter expert and cross-functional leader without direct people-management responsibility.

Responsibilities

WHAT YOU'LL DO

• Develop, maintain, and execute the risk-based internal audit universe and annual audit schedule in alignment with the audit strategy and priorities established by the Director, leveraging applicable requirements, process and product risk, prior findings, CAPA effectiveness, external audit outcomes, organizational changes, performance trends, and emerging regulatory intelligence to proactively identify priorities, strengthen compliance, and support continuous organizational improvement.
• Plan, lead, document, and close complex internal audits across Quality System and operational processes, ensuring clear criteria, auditor independence, objective-evidence sampling, defensible conclusions, timely reporting, and appropriate escalation of systemic issues while fostering transparency, accountability, and effective cross-functional engagement.
• Coordinate trained auditors and subject matter experts assigned to the audit program, including agenda development, auditor assignments, conflict-of-interest review, audit preparation, execution expectations, report quality, and follow-up, promoting a collaborative and solutions-oriented audit culture without direct supervisory responsibility.
• Monitor audit-plan execution, overdue findings, recurring themes, closure quality, and effectiveness evidence; provide routine status, trend, and risk insights to Quality leadership and Management Review to support informed decision-making and sustainable compliance performance.
• Lead assigned external audit and inspection readiness activities and serve as the Director’s primary technical and operational partner for FDA, notified body, MDSAP, customer, and other regulatory or certification audits, including readiness plans, mock audits, SME preparation, evidence-room strategy, request tracking, interview coaching, daily debriefs, and rapid escalation of potential risks to ensure organizational preparedness and confidence.
• Serve as a core front-room or back-room leader, as designated by the Director, during external audits and inspections, coordinating objective evidence, controlling responses to requests, maintaining accurate issue logs, and helping the organization provide clear, consistent, and supportable explanations that reflect a commitment to quality and integrity.
• Coordinate development, review, and timely delivery of external audit responses and remediation commitments in partnership with the Director and responsible process owners, ensuring findings are accurately understood, root causes and actions are systemic, commitments are controlled, and supporting evidence is complete and traceable, with a focus on driving meaningful and lasting improvements.
• Capture lessons learned from internal and external audits and translate them into practical enhancements to procedures, training, readiness tools, audit methods, risk reviews, CAPA activities, and future audit planning to continuously strengthen organizational effectiveness.
• Own the development and monthly publication of the regulatory intelligence newsletter under the regulatory intelligence framework established by the Director, summarizing relevant new or changing regulations, standards, guidance, enforcement themes, and notified-body expectations in concise business language with source attribution, applicability, potential impact, owners, and required follow-up clearly distinguished to enable proactive compliance and informed action.
• Partner with Regulatory Affairs, Quality Systems, Design Assurance, Supplier Quality, Operations, R&D, Clinical, Post-Market, and other subject matter experts to support applicability and impact assessments and ensure identified regulatory intelligence is routed into controlled assessment and implementation processes. Escalate potentially significant changes to the Director and appropriate functional owners for formal decision-making while fostering alignment and shared ownership across teams.
• Manage assigned regulatory intelligence sources, trackers, review cadence, issue prioritization, and traceability from identified change through assessment, decision, implementation action, training, audit verification, or documented rationale, with routine reporting to the Director on status, risk, and overdue actions to ensure accountability and execution.
• Serve as the audit and regulatory intelligence subject matter expert for AI agents developed under the Applied AI Architecture program. Partner with the Director and cross-functional users to define use cases, source requirements, expected outputs, test scenarios, acceptance criteria, known failure modes, and human-review requirements for approved agents supporting audit preparation, evidence review, regulatory intelligence, readiness assessment, cross-document consistency, trend detection, and audit-response quality, advancing thoughtful and responsible innovation.
• Execute assigned AI-agent testing, document results, identify output weaknesses or unsupported conclusions, recommend improvements, and support controlled deployment and ongoing performance monitoring in ac