Staff Auditor, Audit Readiness & Regulatory Intelligence at Endologix LLC in US-CA-Santa Rosa

Job description

• Join our innovative, mission-driven Quality team as a Staff Auditor, Audit Readiness & Regulatory Intelligence at Endologix!
• The Staff Auditor, Audit Readiness & Regulatory Intelligence 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

• 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 accordance with the governance model established by the Director, including defined intended use, source boundaries, human oversight, change control, and issue escalation to ensure reliability, transparency, and continuous learning.
• Develop and maintain audit procedures, templates, playbooks, checklists, training materials, metrics, dashboards, and standardized methods that improve audit consistency, efficiency, traceability, and inspection defensibility while enabling scalable and sustainable quality practices.
• Provide the Director with routine audit-program, external-readiness, regulatory-intelligence, and AI-agent performance updates, including emerging risks, systemic trends, overdue actions, resource constraints, and matters requiring leadership escalation or strategic decision-making. Perform other duties as assigned in support of organizational objectives and the delivery of high-quality outcomes.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related discipline; Master’s degree preferred.
• Minimum of 8 years of progressive experience in medical device (or related regulated industry) Quality Assurance, auditing, regulatory compliance, or Quality Systems, including substantial experience leading internal audits and supporting regulatory or notified-body audits.
• Current ISO 13485 Lead Auditor certification is required.
• Demonstrated working knowledge of FDA Quality Management System Regulation (QMSR), ISO 13485, and Regulation (EU) 2017/745 (EU MDR) is required.
• Demonstrated experience creating risk-based audit schedules, leading cross-functional audit readiness, writing audit reports and responses, and translating regulatory changes into actionable Quality System requirements.
• Advanced knowledge of audit principles and practices, including risk-based planning, auditor independence, objective-evidence sampling, interviewing, finding classification, report writing, follow-up, and effectiveness verification.
• Enterprise internal audit program design, audit-universe maintenance, annual scheduling, auditor coordination, execution, reporting, trending, and Management Review input
• FDA inspection, notified-body, MDSAP, and other external audit readiness, execution support, response coordination, and remediation follow-up
• Regulatory intelligence monitoring, applicability assessment, impact communication, implementation traceability, and concise newsletter development
• Ability to interpret and apply ISO 13485, FDA QMSR, EU MDR, MDSAP requirements, and relevant guidance within a practical medical device Quality Management System.
• Ability to evaluate complex Quality System evidence, identify systemic and cross-process risks, distinguish isolated issues from broader control failures, and communicate conclusions clearly and objectively.
• Excellent technical writing and editorial judgment, including the ability to produce concise audit reports, executive summaries, regulatory intelligence updates, readiness materials, and defensible response language.
• Strong facilitation, interviewing, organization, and communication skills, with the confidence to challenge unsupported statements and guide senior leaders and subject matter experts during high-pressure audits.
• Ability to lead through influence, coordinate multiple functions, maintain independence and professional skepticism, and manage sensitive information appropriately.
• Experience applying AI-assisted review, analytics, or automation to regulated Quality work, with understanding of human oversight, evidence constraints, testing, validation, monitoring, and controlled deployment expectations.
• Advanced project-management skills, including prioritization, schedule ownership, issue escalation, action tracking, and execution across multiple concurrent audits and readiness workstreams.
• Willingness to travel domestically and internationally to support internal audits, supplier or site audits, notified-body audits, regulatory inspections, and readiness activities.
• Experience with Class II or Class III medical devices, implantable devices, global or multi-site Quality Systems, technical documentation, supplier or contract manufacturer audits, and FDA or EU notified-body inspections is highly desired.
• Additional auditor credentials, ASQ certification, MDSAP experience, regulatory intelligence experience, and hands-on experience developing or testing Microsoft Copilot or other controlled AI agents are strong pluses.

Skills

Required

• Ability to lead through influence
• ISO 13485
• FDA QMSR
• EU MDR
• MDSAP
• Microsoft Copilot (preferred)

Benefits

• At Endologix, we know that great work starts with great people — and people do their best when they feel valued and supported. That’s why we offer competitive pay, solid benefits, career growth, a culture that genuinely cares, and the flexibility you need to thrive both at work and at home. But more than that, we offer purpose. You’ll be part of a team that’s making a real impact on patients’ lives. When you join us, you’re not just taking a job, you’re building a meaningful career with a team that’s invested in your success.
• Base Salary of 110,000-$127,500/yr
• 10% 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
• Employee wellness initiatives, mental health resources, and Employee Assistance Program (EAP)
• Employee recognition programs and awards
• Commuter benefits or transportation stipends