Sr. Regulatory Affairs Specialist

Endologix; California; Hybride; USD 110 000 - 128 000; Plein temps

Avantages offerts par ce poste

Discretionary bonus

Equity participation

Health, dental, vision insurance

HSAs/FSAs

Paid time off

401(k)

Résumé du poste

Endologix is seeking a Sr. Regulatory Affairs Specialist to join our mission-driven Regulatory Affairs team.

You will support, develop, and drive the timely preparation of regulatory submissions and product updates to obtain and maintain regulatory approvals for Endologix products, including design changes and manufacturing changes. The role requires 5+ years in medical device regulatory affairs with experience in Class III submissions, and strong knowledge of FDA, EU MDR, ISO 13485, and risk

Qualifications

• Bachelor's degree in scientific discipline or equivalent education and experience.
• 5+ years of medical device experience with 1+ years of Regulatory Affairs.
• Experience leading successful Class III regulatory submissions.
• Knowledge of FDA, EU MDR, and ISO 13485 requirements.
• Strong communication with R&D, Quality, Marketing, and Manufacturing teams.

Responsabilités

• Develop regulatory processes and SOPs with a focus on product quality and patient safety.
• Lead multi-country regulatory strategies (U.S., EU, Canada).
• Prepare and submit regulatory filings and maintain technical documentation.
• Monitor evolving regulations and provide proactive regulatory guidance.
• Collaborate with cross-functional teams to ensure compliant product lifecycle.

Connaissances

Regulatory submissions

FDA knowledge

Cross-functional work

Attention to detail

Technical writing

Reading complex docs

Formation

Bachelor's degree

Master's degree

Outils

MS Word

Excel

PowerPoint

Adobe Acrobat

Description du poste

Join our mission-driven Regulatory Affairs team as the Sr. 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 Sr. 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:

• Develop, implement, and maintain regulatory processes and SOPs with a strong commitment to Integrity, ensuring compliance with current and evolving global regulations and prioritizing product quality and patient safety.
• Provide regulatory leadership and input to product lifecycle planning to support patient outcomes and enable timely access to life-improving therapies.
• Assist in the development and execution of multi-country regulatory strategies (U.S., EU, and Canada), applying innovative and adaptable approaches to evolving regulatory and product requirements.
• Leverage advanced technical and regulatory expertise to propose bold, well-reasoned strategies that resolve complex regulatory challenges while maintaining compliance.
• Determine, interpret, and support fulfillment of submission and approval requirements with transparency, accountability, and attention to detail.
• Review analytical and clinical protocols to ensure appropriate data collection that supports robust regulatory submissions and protects patient outcomes.
• Participate in cross-functional risk management activities, contributing regulatory insight to proactively mitigate potential patient, product, and compliance risks.
• Stay current on new and revised regulations, guidances, and industry trends, evaluating impact and driving informed, forward-looking regulatory decisions.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and collaborate across teams to develop effective, compliant solutions.
• Serve as a core regulatory team member, providing sustained regulatory leadership and partnership to cross-functional project teams.
• Assess the acceptability of quality, preclinical, and clinical documentation to ensure submissions meet regulatory expectations and uphold Endologix’s quality standards.
• Compile, prepare, review, and submit regulatory submissions to global regulatory authorities; interact with authorities professionally and responsively to support timely approvals.
• Build and strengthen relationships with senior internal and external stakeholders through effective communication, collaboration, and influence, adapting messaging to diverse audiences and advising on complex regulatory matters.
• Monitor the impact of changing regulations on submission strategies and communicate implications clearly and proactively to relevant stakeholders.
• Track applications under regulatory review and communicate status, risks, and timelines transparently to cross-functional partners.
• Monitor and submit required regulatory reports, ensuring accurate, timely responses that reflect ownership and accountability.
• Evaluate proposed preclinical, clinical, design, and manufacturing changes to determine appropriate regulatory filing strategies that balance compliance with innovation.
• Negotiate and interact with regulatory authorities during development and review processes with professional integrity to facilitate submission approvals.
• Provide strategic regulatory input and technical guidance to development teams, enabling informed decision-making and cross-functional alignment.
• Review proposed post-market changes to determine regulatory impact and required submission pathways, ensuring continued compliance and product availability.
• Maintain and update Technical Files and Design Dossiers to support product continuity and regulatory readiness.
• Oversee regulatory processes related to annual licenses, registrations, listings, and patent information to ensure sustained market compliance.
• Ensure ongoing compliance with post-market regulatory requirements, reinforcing Endologix’s commitment to patient safety and product excellence.
• Perform other duties as assigned, supporting team objectives and organizational priorities through collaboration and adaptability.

Qualifications

WHAT YOU'LL BRING:

Education:

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

Experience:

• Minimum 5+ years of medical device experience with 1+ years of experience in Regulatory Affairs (with a Bachelor's degree), required.
• 3+ years of medical device experience with 1+ years of experience in Regulatory Affairs (with a Master’s degree), preferred.
• Experience leading successful Class III regulatory submissions.

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 regulatory excellence.
• Strong understanding of design controls, ISO 13485, and risk management principles (ISO 14971), ensuring quality, safety, and integrity throughout the product lifecycle.
• Advanced technical proficiency with the ability to read, analyze, and interpret complex technical documents and publications, applying curiosity and innovative thinking to regulatory challenges.
• Demonstrated attention to detail and analytical rigor, with the ability to interpret complex data and produce clear, accurate, and compliant documentation that reflects accountability and transparency.
• Proven ability to manage multiple regulatory submissions, track competing deadlines, and collaborate effectively with cross-functional teams to meet business and compliance objectives.
• Effective communicator who partners closely with R&D, Clinical, Quality, Marketing, and Manufacturing teams to drive aligned, patient-focused regulatory outcomes.
• Upholds the highest ethical standards, ensuring labeling, advertising, and promotional materials meet regulatory requirements and reflect Integrity Defines Us.
• Strong understanding of how regulatory decisions influence product lifecycle management, market strategy, and commercialization, enabling bold, informed decision-making.
• Proactively monitors evolving global regulations and guidance, using insights to continuously improve processes and advance regulatory capabilities.
• 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 $110,000-$127,500/year
• 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:

• Employee wellness initiatives, mental health resources, and Employee Assistance Program (EAP)
• Employee recognition programs and awards
• Commuter benefits or transportation stipends

OUR COMMITMENT TO EQUAL OPPORTUNITY AND VETERAN INCLUSION:

Endologix LLC is an Equal Opportunity and Aff…

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.