Medical Device Complaint Specialist

Regulatory Knowledge: Direct working knowledge of US FDA 21 CFR 803 (MDR), FDA 21 CFR 820, ISO 13485, MDSAP, EU MDR/MDD vigilance reporting, and international regulatory requirements. Position Summary: The Senior Post-Market Complaint Specialist oversees the maintenance and continuous improvement of the Post-Market Surveillance (PMS) system for surgical robotic products.

Work Location: San Jose (Hybrid Role)


Position Summary: The Senior Post-Market Complaint Specialist oversees the maintenance and continuous improvement of the Post-Market Surveillance (PMS) system for surgical robotic products. This position independently manages the end-to-end complaint lifecycle—from initial intake, investigation, and risk assessment through mandatory domestic and international adverse event reporting and complaint closure.


Essential Duties & Responsibilities:

• Maintain and enhance the Post-Market Surveillance (PMS) system in compliance with regulatory and Quality Management System (QMS) standards.
• Independently execute complaint intake, root-cause investigation/analysis, reportability assessments, and timely complaint file closures.
• Evaluate complaint records for accuracy and thoroughness, executing follow-up actions as necessary to ensure audit-ready files.
• Conduct Good Faith Efforts to retrieve return products and gather required details for safety and functional evaluations.
• Collaborate cross-functionally with Medical Affairs, Customer Service, Global Sales, Professional Educators, and Clinical Specialists to obtain complete event data.
• Determine adverse event reportability and submit timely reports to global regulatory bodies (e.g., US FDA 21 CFR 803, EU MDR/MDD, Health Canada, PMDA, NMPA) per mandated timelines.
• Perform trend analysis on PMS data, draw actionable conclusions, and present findings to leadership and during monthly complaint review meetings.
• Identify emerging product issues, failure modes, or complaint trends; initiate immediate remedial actions or risk mitigations as appropriate.
• Collaborate with Design Quality Engineering to update Risk Management files (e.g., FMEA) when new failure modes or frequency increases are identified.
• Initiate and support Corrective and Preventive Actions (CAPA) and Supplier Corrective Action Requests (SCAR) driven by PMS findings.
• Draft and maintain PMS documentation, including PMS Plans, PMS Reports (PMS-R), and Periodic Safety Update Reports (PSUR).
• Support internal and external regulatory audits, inspections, and customer inquiries regarding failure analysis results.
• Maintain compliance with company QMS standards and Environmental Health and Safety (EHS) policies.

Minimum Required Qualifications:

• Education: Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline (or equivalent combination of formal education and relevant professional experience).
• Experience: Minimum of 5 years of direct experience handling medical device complaints and/or post-market surveillance in a regulated medical device environment.
• Work Arrangement: Ability to work in a hybrid capacity as required by business needs.
  
  

Preferred Qualifications & Skills:

• Regulatory Knowledge: Direct working knowledge of US FDA 21 CFR 803 (MDR), FDA 21 CFR 820, ISO 13485, MDSAP, EU MDR/MDD vigilance reporting, and international regulatory requirements.
• Professional Capabilities: Proven ability to manage multiple regulatory projects independently, prioritize deliverables effectively, and collaborate smoothly across cross-functional teams.
  
  

Flexible work from home options available.