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Overcoming the limitations of conventional CRT through Wireless, LV Endocardial Pacing
Senior QA PMS Clinical Analyst – Lead
Location
United States
Posted
59 days ago
Salary
$115.5K - $156.4K / year
Seniority
Senior
Job Description
Senior QA PMS Clinical Analyst – Lead
EBR Systems, Inc.
• 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.
Job Requirements
- 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).
- 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.
Benefits
- Medical, dental, and vision insurance provided at no cost for employee-only coverage
- 401(k) matching plan
- Paid Time Off – starting at 3 weeks per year
- Competitive salary with opportunities for career growth
- Employee stock options
- Life & AD&D and long term disability insurance
- Education assistance
- Voluntary commuter benefits and pet insurance
- Weekly company lunches and occasional happy hour events
- Meaningful work and much more!
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