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

Educati