Senior Director/Director of Global Regulatory Affairs (Onsite/Remote)

Description

The Senior Director/Director of Global Regulatory Affairs leads global regulatory operations, ensuring strategic oversight and execution across multiple markets. This role manages the regulatory affairs team, drives global submission strategies, ensures compliance with evolving regulations, and collaborates cross-functionally to bring EBR products to market efficiently. The individual is responsible for resource planning, functional leadership, regulatory budgeting, and regulatory risk management while ensuring alignment with business goals. 

Location: Onsite-Sunnyvale, California (preferred) or Remote

Requirements

Essential Duties and Responsibilities include, but are not limited to the following: 

Leadership & Strategy

· Lead the end-to-end global regulatory function, from product inception through lifecycle management.

· Develop and implement global regulatory strategies to obtain and maintain approval of EBR’s portfolio.

· Guide regulatory teams in aligning with regional requirements and corporate objectives.

· Develop resource allocation, regulatory budgets, and headcount planning to support company objectives.

· Build strong relationships with FDA, Notified Bodies, Competent Authorities, and industry organizations.

· Ensure compliance while aligning regulatory strategies with evolving business needs.

· Manage and report on the global regulatory portfolio to the Chief Regulatory Officer and Senior Leadership Team (SLT), ensuring  

visibility into regulatory progress, risks, and opportunities.

· Develop and maintain regulatory dashboards, providing strategic insights into submission timelines, approvals, and compliance status.

Regulatory Execution & Compliance

· Oversee global regulatory submissions, including IDE, PMA, Technical Files, and international product registrations.

· Ensure compliance with FDA, EU MDR, ISO, QSR, and other global regulatory requirements.

· Provide oversight for regulatory risk assessments, supporting strategic decision-making and portfolio selection.

· Ensure regulatory documents are grammatically correct, properly formatted, and free from punctuation errors before submission.

· Supervise regulatory interactions with health authorities, ensuring regulatory managers and specialists conduct conversations effectively.

· Support inspection readiness and audit responses, ensuring regulatory compliance across all operations.

Cross-Functional Collaboration

· Partner with R&D, Quality, Clinical, Marketing, and Commercial teams to ensure regulatory strategies align with business needs.

· Provide regulatory support for clinical trials and post-market activities, ensuring compliance with regulatory requirements.

· Support commercial teams in understanding regulatory limitations on marketing, sales, and contracting before product approval.

· Review company documentation to ensure compliance with regulatory requirements.

Team Development & Performance Management

· Attract, retain, and develop a high-performing global regulatory team, ensuring career growth and functional excellence.

· Establish key performance indicators (KPIs) and drive continuous improvement in regulatory processes.

· Lead regulatory professionals' hiring, onboarding, and development, ensuring succession planning and skills development.

· Cultivate a culture of accountability, collaboration, and proactive problem-solving within the regulatory function.

· Successfully attract, retain, and develop top regulatory talent to strengthen the department’s capabilities.

Stakeholder & External Engagement

· Support regulatory strategy discussions to drive product launch and post-market expansions.

· Monitor evolving regulatory landscapes, assessing impacts on the company's portfolio and ensuring the organization remains proactive.

· Serve as the primary regulatory point person for emergent issues in manufacturing and operations, ensuring timely regulatory guidance and resolution.

Supervisory Responsibilities:

· Lead, mentor, and develop a high-performing global regulatory team, ensuring career growth and functional excellence.

· Establish key performance indicators (KPIs) and drive continuous improvement in regulatory processes.

· Oversee the hiring, onboarding, and development of regulatory professionals, ensuring succession planning and skills development.

· Cultivate a culture of accountability, collaboration, and proactive problem-solving within the regulatory function.

Requirements

Education and Required Experience:

· Bachelor’s degree in engineering, regulatory affairs, quality assurance or other science/technical related discipline is required. Advanced degree in a scientific, medical, or clinical field  (MD, PhD, PharmD, or MS with extensive experience in clinical research) is preferred.

Director level

· A minimum of 7 years of experience in global regulatory affairs in medical devices or related industries.

· Experience managing regulatory staff, including hiring, training, and development.

· Experience supporting regulatory negotiations with FDA, Notified Bodies, and other health authorities under the guidance of senior regulatory leadership.

· Experience assisting in regulatory budgeting, resourcing, and planning, with increasing responsibility for managing aspects of regulatory operations.

Senior Director level 

· A minimum of 10 years of experience in global regulatory affairs with leadership responsibility.

· Extensive experience leading global regulatory teams and securing approvals for complex Class III medical devices.

· Experience in regulatory budgeting, resourcing, and long-term regulatory planning.

 Knowledge, Skills, and Abilities: 

· Exceptional written and verbal communication skills, with the ability to influence senior stakeholders.

· Proficiency in regulatory, digital tools, documentation systems, and compliance databases.

· In-depth knowledge of FDA, EU MDR, ISO, and post-market surveillance requirements.

· Proficiency in MS Word, Excel, PowerPoint, Teams, and Adobe Pro.

Director Level

· Strong knowledge of regulatory intelligence, competitive analysis, lifecycle management, and strategic planning, with the ability to apply insights to regulatory submissions.

· Proven track record of navigating global regulatory pathways and obtaining approvals for Class III medical devices.

· Ability to contribute to regulatory strategy development, ensuring alignment with evolving business needs and compliance requirements.

Senior Director Level

· Strong ability to attract, retain, and develop high-caliber regulatory professionals.

· Demonstrated success in regulatory negotiations with FDA, Notified Bodies, and other health authorities.

· Deep understanding of regulatory intelligence, competitive analysis, lifecycle management, and strategic planning.

· Ability to align regulatory strategy with evolving business needs while ensuring compliance.

Physical Requirements:

· Willingness and able to travel approximately 25% of the time, including visits to the EBR main office (up to one week per month) and attendance at industry events. Travel may include weekends and overnight stay. 

· Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms. Required to stoop, kneel, bend, crouch and lift up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, depth perception, color vision and the ability to adjust focus.

· Subject to extended periods of sitting and/or standing, vision to monitor, and moderate noise levels. 

Salary Range: $176,000 - $235,000*

*Base pay is one part of your total compensation. The salary offered will depend on several factors, including, but not limited to your experience, knowledge, skills, location, internal equity, and market alignment. Addition compensation may include bonuses and equity, along with a comprehensive benefits package.  

EBR Systems, Inc. is an Equal Opportunity Employer committed to a diverse, inclusive, and equitable workplace. 

EBR Systems, Inc. does not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. Please refrain from solicitations at this time.

Company Overview

Silicon Valley-based EBR Systems is dedicated to superior treatment of cardiac rhythm disease by providing more physiologically effective stimulation through wireless cardiac pacing. The company’s patented proprietary Wireless Stimulation Endocardially (WiSE) technology was developed to eliminate the need for cardiac pacing leads, historically the major source of complications and reliability issues in cardiac rhythm disease management.

We are a team of dedicated individuals, driven to deliver superior treatment of millions of patients suffering from cardiac rhythm diseases by developing safe, clinically superior, cost-effective, and reliable therapies using wireless cardiac stimulation. As a fast-paced company, every team member at EBR makes a big contribution towards our mission. We seek candidates who are passionate about improving #healthcare and motivated to do the hard and exciting work required to bring ground-breaking technology to market.

EBR Systems, Inc. offers a great place to work as well as generous benefits and growth opportunities:

• Medical, dental, and vision insurance provided at no cost for employee-only coverage 
• 401(k) matching plan
• Paid Time Off – starting at 3 weeks per year
• Competitive salary with opportunities for career growth
• Employee stock options
• Life & AD&D and long term disability insurance
• Education assistance
• Voluntary commuter benefits and pet insurance 
• Weekly company lunches and occasional happy hour events
• Meaningful work and much more! 

 Please visit us at https://www.ebrsystemsinc.com/ to learn more about our company.