EBR Systems, Inc.

• Maintain and update study information on ClinicalTrials.gov, ensuring accuracy and compliance with regulatory requirements • Perform document filing, tracking, and maintenance within Veeva Vault, ensuring all study documents are current, complete, and audit-ready • Assist with EDC (Electronic Data Capture) data management activities and adding users • Assist with data entry and data verification activities for the TLC study, ensuring high level of accuracy and timeliness • Support site data maintenance in the BSI CTMS, including updating site information and tracking site status • Assist with quality checks and reconciliation across clinical systems to ensure consistency of study data • Collaborate with Clinical team members to support study start-up, maintenance, and close-out activities as needed • Adhere to SOPs, ICH-GCP guidelines, and applicable regulatory requirements in all assigned

• The Senior Clinical Research Associate is accountable for monitoring excellence, data integrity, and site engagement across the full lifecycle of a clinical study. • Ensure studies are conducted compliantly, data are reliable, and sites are operationally and clinically supported from start-up through close-out. • Actively support enrollment and follow-up performance, and engage with site teams on the clinical substance of the work. • Collaborate with internal clinical teams in the execution of the study to achieve study goals and milestones. • Monitor subject enrollment progress across assigned clinical study sites to ensure enrollment targets and timelines are met.

• The Clinical Data Manager (or Senior Clinical Data Manager, based on experience) will lead database development and management efforts — encompassing EDC, eTMF, and CTMS systems. • This role requires deep expertise in clinical data management and system build, as well as proficiency in data visualization. • The ideal candidate will have demonstrated hands-on experience designing, building, implementing, and maintaining clinical data systems from the ground up, ensuring high-quality data outputs that support regulatory submissions and cross-functional decision-making. • This individual will serve as the functional owner of all clinical data systems and infrastructure and will be expected to assess, revise, and strengthen existing SOPs and data management processes to meet regulatory and operational standards. • Lead development, implementation, and ongoing management of eTMF and CTMS systems in collaboration with Clinical Affairs, Regulatory Affairs, and IT stakeholders.

• Develop and implement a comprehensive territory business plan and meet or exceed quarterly and annual sales objectives. • Identify and engage new business opportunities, leveraging proven sales strategies to drive results. • Present and demonstrate products to physicians and hospital personnel, conduct clinical in-services and training sessions. • Build and sustain long-term, trust-based relationships with key customers and healthcare providers. • Analyze market trends, competitor activities, and customer feedback to inform strategic territory planning. • Maintain comprehensive knowledge of product features, clinical evidence, and appropriate patient selection criteria. • Partner with marketing, product management, and operations teams to ensure consistent messaging and timely product availability. • Accurately document and analyze sales activities, pipeline status, and account information in CRM systems. • Participate in continuous learning opportunities to stay informed about the latest product developments and clinical guidelines.

• 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. • 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. • Provide expert clinical and technical analysis to support root cause determination, including differentiation between device-related, use-related and patient specific factors. • 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. • Serve as Clinical Quality SME supporting cross-functional collaboration across Quality, Regulatory Affairs, R&D, Manufacturing, and Clinical teams.

• 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.

• 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.

• 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.

• Represents the Regulatory Affairs function in project teams and leads regulatory projects 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. • Assists with the training and mentoring of other Regulatory Affairs team members. • Represents RA department in assigned project meetings and provides regulatory guidance to ensure adherence with global regulatory requirements as appropriate. • Evaluates possible pathways to marketing authorization and recommends pathway that appropriately weighs the probability of success with potential risks to the business. • Develops and executes sound regulatory strategies to support business goals with minimal oversight. • Assesses product and manufacturing changes and develops well-justified regulatory assessments for each global market. • Reviews and approves document change orders, advertising and promotional material, manufacturing nonconformances, technical documents, test protocols and reports, risk management documents, and labeling documents. • Directly interacts with regulatory bodies in the US and/or international regions to ensure projects remain on track and issues are resolved. • Develops, prepares, and submits high quality technical documentation/submissions for regulatory approval in the US and other international regions. • Establishes timelines, manages sub-team meetings relevant to regulatory processes, and ensures timely execution. • Prepares reports for management and develops metrics and proposals for regulatory process improvements.