EBR Systems, Inc.

Compliance

• Represents the Regulatory Affairs department in assigned project teams and provides regulatory input in accordance with established timelines to meet corporate objectives.
• Develops and executes sound regulatory strategies to support business goals.
• Oversees and ensures compliance with state, federal, and international medical device regulations and overall regulatory departmental objectives for new and existing products.
• Independently assesses product and manufacturing changes and develops well-justified regulatory assessments for each global market.
• Develops, prepares, and submits high quality technical documentation/submissions for regulatory approval in the US and other international regions.

Senior Regulatory Affairs Specialist

Program Manager

• Lead and execute scientific affairs programs aligned with medical and corporate strategy
• Proactively prioritize, identify, assess, and critically summarize relevant scientific and medical literature across therapeutic area.
• Synthesize, assess, and communicate potential impact of key findings to internal stakeholders
• Interpret study results and collaborate with Health Care Professionals (e.g., study Investigators, physician) in the development of scientific communications content, such as conference proceedings (e.g., abstracts and presentations) and/or journal manuscripts
• Initiate data analysis of clinical data sets and provide strategic recommendations to key stakeholders
• Lead conference coverage of all major relevant medical/scientific conferences and synthesize and disseminate the summaries
• Conduct literature review to address internal and external medical information queries
• Provide input to set the Global strategy of medical/scientific podium and publication programs
• Develop and cultivate strong relationships with key academic institutions, physicians, KOLs, hospitals, scientific societies and associations to facilitate scientific communication efforts
• Lead the continued development of the scientific content repository
• Drive publication planning and execution, including manuscripts, abstracts, podium presentations, and society submissions
• Serve as primary liaison for external authors and internal cross-functional contributors
• Support development of clinical studies, market access studies, and post-approval evidence generation programs
• Contribute to Healthcare Economics & Outcomes Research strategies and value-based evidence development
• Partner closely with R&D, Clinical, Regulatory, Training & Education, and Quality to support product development, post-market surveillance, and lifecycle management
• Collaborate with Commercial leadership to ensure scientific accuracy and compliance of materials
• Support Market Access initiatives with evidence packages and clinical value narratives
• Translate complex clinical data into compelling, compliant messaging
• Manage timelines, budgets, and vendors for publication and scientific programs
• Ensure alignment with regulatory and compliance requirements
• Operate effectively in a lean environment with evolving priorities

Scientific Affairs Program Manager

Director

• Leading the design, execution, and optimization of all US training programs supporting physicians, Field Clinical Specialists, and commercial teams.
• Partnering with the Senior Director, Global Training & Education to ensure the US training strategy aligns with the company’s global educational framework.
• Building and managing a high-performing US training organization.
• Overseeing the delivery and enhancement of multi-modal training programs ensuring consistency with global standards.
• Partnering with the Global Director to embed US training programs within the company’s Quality Management System (QMS) and maintain adherence to compliance standards.
• Establishing US specific KPIs to measure training program success and provide consolidated reporting to the Global Director of Training & Education.
• Representing the company at domestic and international conferences, advisory boards, and physician training events.

US Director of Training

Engineer

• Serve as a clinical and technical subject matter expert within Quality Assurance and provides advanced clinical expertise to assess device performance concerns, determine regulatory reportability, identify root causes, and support risk management activities.
• Play a key role in ensuring regulatory compliance, identifying safety signals, and supporting product quality and patient safety.
• Collaborate cross-functionally with Quality, Regulatory Affairs, R&D, Manufacturing, and Clinical teams to evaluate complaints, interpret clinical and device data, and ensure accurate, compliant complaint handling in accordance with FDA, EU MDR, and other global regulatory requirements.
• Partner closely with Field Clinical and Technical teams to ensure timely reporting of device-related issues and collection of complete, high-quality information to support thorough complaint investigation and evaluation.
• Act as senior clinical and technical SME for complaint investigations involving implantable medical devices including assessment of device performance and patient outcomes.
• Support Quality Leadership in identifying emerging product performance trends, reliability concerns, and potential risk signals through complaint trending and data analysis.
• Perform global regulatory reportability assessments in accordance with applicable regulations, including FDA Medical Device Reporting (21 CFR 803), EU MDR Vigilance Reporting, TGA, PMDA, MHRA, and other international regulatory requirements.
• Provide clinical and technical input to support regulatory submissions, responses to Competent Authority inquiries, and vigilance reporting activities.
• Participate in cross-functional reviews of complaint trends, product performance, reliability, and patient safety.
• Support internal audits, external audits, and regulatory inspections related to complaint handling, vigilance reporting, and post-market surveillance activities.
• Drive continuous improvement of post-market surveillance (PMS) and complaint handling processes.

Senior Regulatory Affairs Specialist

Scientific Affairs Program Manager

US Director of Training

Senior Lead Field Clinical Engineer