EBR Systems, Inc.

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 Lead Field Clinical Engineer

Compliance

• 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.

Senior Lead Field Clinical Engineer

Principal Regulatory Affairs Specialist