Regulatory Affairs Specialist

Overview

Join our Regulatory Affairs team as a 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 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:

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 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:

We’re looking for a Regulatory Affairs Specialist to join our mission-driven Regulatory Affairs team. In this role, you’ll 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.

Responsibilities

WHAT YOU'LL DO:

• Support and maintain regulatory processes and SOPs with integrity and transparency, ensuring ongoing compliance with current and evolving regulations while prioritizing quality and patient safety in alignment with Endologix’s commitment to improving patient outcomes.
• Develop and update multi-country regulatory strategies in response to regulatory and product changes, applying innovative and adaptable thinking to support timely patient access to therapies.
• Review analytical and clinical protocols to ensure the collection of robust, high-quality data that supports sound regulatory submissions and advances patient-focused decision-making.
• Stay current on new and revised regulations, guidance, and industry publications, proactively assessing impact and applying insights to support innovative, compliant, and patient-centered regulatory approaches.
• Anticipate regulatory obstacles and emerging issues across the product lifecycle, taking bold yet informed action and partnering cross-functionally to develop effective, compliant solutions.
• Serve as a regulatory core team member, collaborating closely with project teams to deliver regulatory guidance that supports timely innovation and exceptional patient outcomes.
• Assess the acceptability of quality, preclinical, and clinical documentation to ensure submissions meet regulatory expectations and reflect Endologix’s high standards of excellence and accountability.
• Compile, prepare, review, and submit regulatory filings to health authorities accurately, efficiently, and with ownership, and interact with regulatory agencies in a professional, responsive, and transparent manner.
• Build productive internal and external relationships by collaborating across functions to resolve challenges, provide professional regulatory guidance, and prepare analyses that support informed decision-making.
• Monitor the impact of regulatory changes on submission strategies and clearly communicate implications to stakeholders, enabling coordinated, proactive action.
• Track applications under regulatory review and provide timely, transparent updates to internal teams, reinforcing trust and collaboration.
• Monitor and submit required regulatory reports, ensuring ethical conduct, regulatory integrity, and timely compliance.
• Evaluate proposed preclinical, clinical, design, and manufacturing changes using sound judgment, adaptability, and strategic insight to determine appropriate regulatory pathways.
• Interact with regulatory authorities throughout development and review processes to support efficient approvals and sustained patient access.
• Review proposed post-market changes to assess regulatory impact and required submissions, ensuring continued compliance, product availability, and patient benefit.
• Complete and maintain Technical Files and Design Dossiers to support regulatory readiness, product continuity, and quality excellence.
• Support regulatory activities related to annual licenses, registrations, listings, and patent information to maintain global market access and compliance.
• Support adherence to post-market regulatory requirements, reinforcing Endologix’s commitment to patient outcomes, quality, and integrity.
• Perform other duties as assigned, demonstrating flexibility, collaboration, and a shared commitment to bold, high-impact excellence.

Qualifications

WHAT YOU'LL BRING:

Education:

• Bachelor's degree in scientific discipline or equivalent education and experience OR Master's degree with 1+ years related experience.

Experience:

• Typically has minimum 2-5 years (1+ years with Master’s degree) medical device experience with 1+ years of experience in Regulatory Affairs.
• Experience with US Class III cardiovascular devices strongly preferred.

Skills/Competencies:

• In-depth knowledge of FDA, EU MDR, and global medical device regulations, with experience preparing and maintaining regulatory submissions and technical documentation that support patient outcomes and sustained market access.
• Solid understanding of design controls, ISO 13485, and risk management principles (ISO 14971), ensuring quality, safety, and integrity throughout the product lifecycle.
• Exceptional attention to detail with the ability to analyze complex data and produce clear, accurate, and compliant documentation, reflecting accountability and regulatory excellence.
• Proven ability to manage multiple submissions, prioritize deadlines, and collaborate effectively across cross-functional teams to deliver results.
• Effective communicator who partners closely with R&D, Clinical, Quality, Marketing, and Manufacturing teams to drive aligned, patient-focused regulatory solutions.
• Demonstrates high ethical standards, ensuring labeling, advertising, and promotional materials meet regulatory requirements.
• Strong understanding of how regulatory decisions influence product lifecycle management, market strategy, and commercialization, enabling informed and bold decision-making.
• Actively monitors evolving global regulations and guidance, applying insights to continuously improve internal processes and regulatory practices.
• Proficient in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat to support efficient, high-quality regulatory documentation and communication.

WHAT WE OFFER:

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.

The compensation package includes:

• Base salary of $90,000/yr-$102,500/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

Plus:

• 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
• Learning and development opportunities
• Commuter benefits or transportation stipends
• Company events and team-building activities

OUR COMMITMENT TO EQUAL OPPORTUNITY & VETERAN INCLUSION:

Endologix LLC is an Equal Opportunity and Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law. As a federal contractor, Endologix LLC is committed to taking affirmative action to recruit, employ, and advance in employment qualified individuals with disabilities and protected veterans.