Regulatory Risk Manager

The Regulatory Risk Manager is responsible for managing customer complaints classified as potential incidents, ensuring full compliance with international regulations (e.g., FDA 21 CFR 820, ISO 13485, MDR).

Key responsibilities include:

• Leading end-to-end complaint handling: intake, investigation, RCA, CAPA, closure, and reporting
• Collaborating with global partners (distributors, subsidiaries) to gather data and provide guidance
• Integrating a CRM-based complaint handling tool to enhance traceability and compliance
• Ensuring accurate documentation, trend analysis, and continuous process improvement
• Supporting regulatory submissions, audits, and Post-Market Surveillance (PMS) activities including PSUR
• Conducting regulatory and clinical assessments of potential incidents
• Providing training to internal teams and external partners on complaint handling procedures
  
  

• Bachelor’s in Life Sciences, Engineering, or related field (advanced/clinical degree preferred)
• 5+ years of experience in complaint handling within the medical device industry, with a focus on adverse events
• Strong understanding of global medical device regulations and risk management principles
• Experience with eQMS, PMS data analysis, PSURs, and regulatory assessments
• Proficiency in RCA tools (5 Whys, Fishbone, etc.) and complaint management software
• Excellent communication, documentation, and analytical skills
• Fluency in English (written and spoken); additional languages a plus
• Familiarity with class IIb HW/SW products, audit processes, and clinical data review