Associate Regulatory Affairs Specialist - International

Overview

Join our Regulatory Affairs team as an Associate Regulatory Affairs Specialist - International 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 an Associate Regulatory Affairs Specialist - International - 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 international regulatory processes and SOPs with a strong commitment to integrity, ensuring ongoing compliance with current and evolving regulations and prioritizing quality and patient safety.
• Stay current on new and revised international regulations, guidance, and industry publications, proactively assessing impact and applying insights to support patient-focused regulatory decisions.
• Assess the acceptability of quality, preclinical, and clinical documentation to ensure submissions meet regulatory expectations and uphold high standards of excellence.
• Compile, prepare, review, and submit high quality regulatory filings to international health authorities accurately and efficiently, demonstrating accountability and ownership.
• Build and maintain effective working relationships internally, collaborating across teams and exchanging information with colleagues, project leaders, and supervisors to support shared objectives.
• Collaborate on EU local registrations and tender requests to ensure accuracy and submission on a timely basis.
• Monitor the impact of international regulatory changes on submission strategies and communicate implications clearly and timely to relevant stakeholders, enabling informed, coordinated action.
• Track applications under international regulatory review and provide transparent updates to internal teams.
• Evaluate proposed preclinical, clinical, design, and manufacturing changes, applying sound judgment and adaptable thinking to develop and implement appropriate international regulatory filing strategies in conjunction with the RA product owner.
• Review proposed post-market changes to assess international regulatory impact and required submissions, ensuring continued compliance and product availability for patients.
• Assist with the processing of Certificate to Foreign Government or Export Certificate for Global registration as required.
• Support regulatory processes related to annual licenses, registrations, listings, and patent information to maintain market access and compliance.
• Perform other duties as assigned, demonstrating flexibility, collaboration, and a shared commitment to excellence.

Qualifications

WHAT YOU'LL BRING:

Education:

• Bachelor's degree in a scientific discipline or equivalent education and experience.

Experience:

• Prior experience in medical device regulatory affairs preferred.

Skills/Competencies:

• In-depth knowledge of international 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 and embody Integrity Defines Us.
• 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 guidances, 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 $75,000/yr-$85,000/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

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.