Sr. Regulatory Affairs Specialist

Endologix•Irvine, CA

1d•$110,000 - $127,500•Hybrid

About The Position

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.

Requirements

Bachelor's degree in scientific discipline or equivalent education and experience, required.
Minimum 5+ years of medical device experience with 1+ years of experience in Regulatory Affairs (with a Bachelor's degree), required.
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.

Nice To Haves

Master's degree with 1+ years of related experience, preferred.
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.

Responsibilities

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.

Benefits

Base salary of $110,000/yr-$127,500/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
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