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.
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.
- 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.
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
