Job Type
Full-time
Description
DescriptionThe Senior QA PMS Clinical Analyst/Lead serves 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. The Senior QA PMS Clinical Analyst/Lead plays a key role in ensuring regulatory compliance, identifying safety signals, and supporting product quality and patient safety.
The Senior QA PMS Clinical Analyst/Lead collaborates 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.
Essential duties and responsibilities include, but are not limited to, the following: - 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.
- Serve as the subject matter expert (SME) on the WiSE system, providing technical and clinical training and guidance to the Quality team.
- 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.
- Provide clinical and technical input to support regulatory submissions, responses to Competent Authority inquiries, and vigilance reporting activities.
- Serve as Clinical Quality SME supporting cross-functional collaboration across Quality, Regulatory Affairs, R&D, Manufacturing, and Clinical teams.
- 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.
- Contribute to continuous improvement initiatives to strengthen complaint handling, investigation rigor, regulatory compliance, and post-market surveillance processes.
Other Duties and Responsibilities: - Drive continuous improvement of post-market surveillance (PMS) and complaint handling processes, including enhancement of procedures, investigation methodologies, templates, and data management systems.
- Support development and implementation of automated tracking tools and visual dashboards to monitor complaint trends, investigation status, and key quality metrics using Excel, Microsoft Planner, and PowerPoint.
- Assist in preparation of management review materials, executive summaries, and quality performance reports based on complaint and PMS data.
- Support initiatives to improve data integrity, traceability, and accessibility of complaint and investigation records.
- Perform additional duties and responsibilities as assigned to support Quality, Regulatory, and Post-Market Surveillance objectives.
Supervisory Responsibilities: - This position has no direct reports and no supervisory responsibilities, but may provide mentoring or task direction to Complaint Analysts, Field Quality Specialists, or temporary support staff.
Education and Required Experience: - Bachelor's degree in nursing or medical field required; active Registered Nurse (RN) or medical license required. Clinical nursing experience in cardiology, electrophysiology, heart failure, or cardiac rhythm management strongly preferred.
- Extensive hands-on experience with Cardiac Rhythm Management (CRM) devices required, including implantable pacemakers, CRT systems, ICDs, leadless pacemakers, and associated programmer systems, with demonstrated understanding of device function, programming, and clinical troubleshooting.
- Minimum of 5-7 years of experience in Post-Market Surveillance, Complaint Handling, Clinical Quality, or Medical Device Quality within the medical device industry, preferably supporting implantable cardiac devices or other Active Implantable Medical Devices (AIMDs).
- Demonstrated ability to apply clinical knowledge to evaluate device-related complaints, assess patient outcomes, and distinguish between device-related, procedural, and patient-specific contributing factors.
- Strong working knowledge of global medical device regulations and standards, including FDA 21 CFR Part 803 (Medical Device Reporting) and Part 820 (Quality System Regulation), EU MDR 2017/745 Vigilance requirements, MEDDEV 2.12-1, ISO 13485, ISO 14971, and international regulatory frameworks including TGA, PMDA, and MHRA.
Knowledge, Skills, and Abilities: - Deep understanding of cardiology and cardiac rhythm management therapies.
- Ability to integrate clinical, technical, and regulatory perspectives into complaint evaluations.
- Advanced proficiency in Microsoft Excel (pivot tables, macros, formulas, charting) and PowerPoint for metric and trend visualization.
- Familiarity with Microsoft Planner for project tracking and task management.
- Excellent written communication skills with the ability to simplify complex technical information.
- Analytical mindset with exceptional attention to accuracy and data integrity.
- Demonstrated ability to work cross-functionally and manage multiple priorities in a fast-paced, regulated environment.
Physical Requirements: - Ability and willingness to travel occasionally within the U.S. up to 10% for audits, training, or complaint investigation support, which may include weekend and overnight stays.
- Required to stand, walk and sit; talk or hear; use hands to finger, handle or feel objects or controls; reach with hands and arms.
- 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: $115,000 - $155,000*
*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. does not accept unsolicited resumes from headhunters, recruitment agencies, or fee-based recruitment services. Please refrain from solicitations at this time. Salary Description
$115,000 - $155,000
