Join our mission-driven Regulatory Affairs team as a Regulatory 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.

ABOUT THE ROLE:

We’re looking for a Regulatory Specialist to join our 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.

WHAT YOU'LL DO:

• Support and maintain regulatory processes and SOPs to ensure compliance with latest applicable regulations.
• Provide regulatory input to product lifecycle planning.
• Update multi-country regulatory strategies based upon regulatory and product changes.
• Support fulfillment of submission and approval requirements.
• Review analytical and clinical protocols to assure collection of appropriate data for regulatory submission.
• Participate in risk management activities.
• Keep abreast of new or revised regulations, proposed regulations and guidances, compliance guides, journals, etc. and determine the impact, if any.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
• Serve as a regulatory core team member and provide ongoing regulatory support to project teams.
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
• Compile, prepare, review, and submit regulatory submissions to regulatory authorities; interact with regulatory authorities to answer questions in a timely manner.
• Monitor impact of changing regulations on submission strategies and communicate to appropriate departmental personnel.
• Monitor applications under regulatory review.
• Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities.
• Evaluate proposed preclinical, clinical, design and manufacturing changes for regulatory filing strategies.
• Interact with regulatory authorities during the development and review process to ensure submission approval.
• Review proposed post-market changes to determine the level of change and any resulting submission requirements.
• Complete and update Technical Files / Design Dossiers necessary for product continuance.
• Support processes involved with maintaining annual licenses, registrations, listings and patent information.
• Support compliance with product post-marketing approval requirements.
• Perform other duties as assigned by supervisor.

WHAT YOU'LL BRING:

Education:

• Minimum bachelor's degree in a scientific discipline or equivalent.

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:

• Knowledge of FDA, EU MDR, and global medical device regulations; experience preparing and maintaining regulatory submissions and technical documentation.
• Understanding of design controls, ISO 13485, and risk management principles (ISO 14971).
• Strong attention to detail, ability to interpret complex data, and produce clear, compliant documentation.
• Ability to manage multiple submissions, track deadlines, and coordinate with cross-functional teams.
• Effective communicator who works closely with R&D, Clinical, QA, Marketing, and Manufacturing teams.
• Upholds high ethical standards; ensures labeling, advertising, and promotional materials meet regulatory requirements.
• Understands how regulatory decisions impact product lifecycle, market strategy, and commercialization goals.
• Stays current with evolving regulations and proactively improves internal processes.

HOW YOU'LL SHOW UP:

All In: Bring full commitment to everything you do. Support one another, hold yourself accountable, and take ownership of your work. Move with urgency, deliver on your promises, and lead with boldness and passion.

Act with Integrity: Prioritize ethics and transparency in every decision. Earn trust by being honest, respectful, and dependable — working diligently to uphold the confidence of your colleagues, customers, and communities.

Tenacious: Meet challenges head-on with resilience and resolve. Stay focused, push through obstacles, and consistently look for solutions, not excuses.

Pioneering: Challenge the status quo and embrace innovation. Develop new ideas, test bold solutions, and pave the way for others — driving progress through curiosity and creativity.

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
• Generous PTO and holiday schedule
• 401(k) retirement plan with company match

Plus:

• Employee wellness initiatives and mental health support
• Collaborative and inclusive company culture focused on impact and innovation
• Opportunities for career growth and internal mobility

OUR COMMITMENT TO DIVERSITY AND INCLUSION:

Endologix LLC.  is an Equal Opportunity 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.