Senior QA PMS Clinical Analyst/Lead
The Senior QA PMS Clinical Analyst/Lead acts as a clinical and technical subject matter expert to manage complaint investigations, regulatory reporting, and post-market surveillance for implantable cardiac devices. The role involves cross-functional collaboration to ensure compliance with global medical device regulations using tools like Excel and Microsoft Planner.
- Compensation
- $115K–$155K / yr
- Location
- Onsite or Remote
- Work setup
- Remote
- Seniority
- Lead
- Employment
- Not specified
- Experience
- Not specified
- Category
- Qa
- Posted
Must have
- Bachelor’s degree in nursing or medical field
- Active Registered Nurse (RN) or medical license
- Extensive hands-on experience with Cardiac Rhythm Management (CRM) devices
- 5–7 years of experience in Post-Market Surveillance, Complaint Handling, Clinical Quality, or Medical Device Quality
- Knowledge of FDA 21 CFR Part 803, Part 820, EU MDR 2017/745, ISO 13485, and ISO 14971
- Advanced proficiency in Microsoft Excel and PowerPoint
Nice to have
- Clinical nursing experience in cardiology, electrophysiology, heart failure, or cardiac rhythm management
Full description
Description
The 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.