Director, Regulatory Affairs

Overview

Join our exciting team as a Director, Regulatory Affairs! 

Endologix, LLC. is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease.  We have a therapeutic portfolio designed to treat diseases which currently have clinically relevant unmet needs. Our existing products can treat a wide spectrum of vascular disease through abdominal aortic aneurysms to lower limb peripheral vascular disease. We obtain excellent clinical outcomes through meticulous attention to product design, manufacturing, and training, all backed by industry-leading clinical evidence. 

The Director, Regulatory Affairs will design, plan, and execute business-aligned strategies for timely and highquality regulatory submissions in close collaboration with marketing, research and development, manufacturing, and clinical affairs partners for optimum achievement of corporate objectives. Manages and mentors regulatory affairs staff. Provides regulatory advice to other departments and executive management. Provides expertise in the interpretation of regulations into practical and workable plans. Together with direct reports, interacts with regulatory agencies. Supports internal and external audits as well as other compliance processes.

Responsibilities

Major Duties:

• Lead and mentor a team of regulatory professionals in various remote/hybrid locations, providing guidance onregulatory issues and coaching on competencies.
• Formulate and implement regulatory strategies for new or modified products, clinical trials, and marketauthorization in various regions, and ensure alignment of regulatory strategies with business objectives andpriorities.
• Oversee timely preparation, review, and submission of regulatory files to regulatory agencies, such as theFDA, notified bodies, and competent authorities, and manage communications and relationships with theseagencies.
• Identify potential regulatory risks and develop mitigation strategies to ensure successful product launches andcompliance throughout the product lifecycle.
• Maintains international and local registrations and ensures compliance with all post-approval commitments.
• Work closely with other functions, including but not limited to research and development, quality assurance,manufacturing, clinical affairs, and marketing, to ensure adherence to regulatory requirements.
• Oversee regulatory review of advertising and promotional materials for appropriateness and substantiation ofproduct claims.
• Interact professionally with all organizational levels and proactively escalate issues to appropriate levels ofmanagement in the organization.
• Develops and delivers presentations to Executive Management and company personnel for educational andcommunication purposes.
• Monitor changes in regulatory policies, guidelines, and regulations and assess their impact on the company’sproducts and operations.
• Implement strategies to streamline processes and identify areas for improved compliance within theorganization.
• Leads the planning and execution of internal and external audit activities, including State of California, US FDA,Notified Bodies, and other international regulatory authorities.
• Oversees the Health Hazard Evaluation and product recall/field safety notice process and associated FieldAction Committee activities.
• Ensures corporate compliance for manufacturing licenses, government reporting requirements, etc.
• Participate actively in budgeting process and ensure department remains within approved budget.
• Perform other duties as assigned by supervisor.
• Up to 25% travel is anticipated.

Qualifications

Education: Bachelor's degree in engineering, science, or a related field.

Experience:

• Minimum 8 years of directly relevant experience (6 years with a Master’s degree) in medical deviceregulatory affairs.
• Experience with implantable medical devices, with US/EU Class III cardiovascular product experience stronglypreferred.
• Direct experience with regulatory submissions such as IDEs, PMAs, or EU MDR technical documentation.
• Demonstrated track record in people management including performance feedback and career development.
• Strong technical proficiency, with ability to read and interpret technical documents and publications.
• Knowledge of US and EU regulations, including EU MDR, and requirements for all risk classifications ofproducts.
• Understanding of design control, risk management, and post-market requirements for medical devices.
• Experience interacting with FDA and/or other regulatory agenci