Post Market Surveillance & Risk Management Specialist

Job Title
Post Market Surveillance & Risk Management Specialist

Job Description

The PMS & RM Specialist is responsible for managing activities related to product safety surveillance and risk management.

Serves as a liaison between Medical Affairs, Clinical Affairs, Research & Development, and Complaint Handling to ensure Post Market Surveillance and Risk Management processes are executed end-to-end .

Reviews and prepares reports on aggregate data and provides recommendation for further escalation. Reviews complaint trend analysis, product risk assessments including Health Hazard Evaluations, clinical evaluation reports, risk management reports and FMEAs. Assists in benchmarking best practices with world-class organizations, interfaces with notified body, and/or other regulators, and provides input to establish metrics.

Your role:

• Ensures standard PMS processes and reports across business units , Assures consistent PMS plans exists for all products and standard process exists to perform proactive surveillance.
• Patient Safety and Regulatory Reporting- In collaboration with Medical Affairs, monitors and assesses safety signals, and recommends actions
• Assesses product relationship to reported complaint.
• Assures standard regulatory reporting assessment criteria
• Provides input to clinical conclusion to be included in the reports to competent authorities
• Supporting standard Risk Management processes: In collaboration with stakeholders, defines standard risk acceptability criteria (RAC) with stakeholders
• Supports the development of consistent RM plans exists for all products
• Provides oversight and clinical guidance on risk assessments including post-market risk assessments and health hazard evaluations
• Assures standard PMS and RM governance across Business Units
• Provides oversight of PMS and RM processes and assures standard approach
• Signal Assessment & Escalation: Ensures standard statistical trending techniques, Assesses significant triggers & safety concerns, Manage recurrent PMS/RM data review meetings
• Represent PMS interests in multi-disciplinary teams during product development.
• Assures development and completion of PMS & RM deliverables throughout the design process
• Provides input of PMS related product risk & quality issues during the development of new products.
• Working site may be Haifa or Ra'anana
  
  

• Bachelor’s degree in life sciences or similar healthcare-related field
• 6+ years of experience in the pharmaceutical / medical device industry or direct device clinical experience
• Regulatory Affairs, Quality Assurance, or Complaint Handling experience in pharmaceuticals or medical devices
• Direct experience/knowledge of most regulations relative to PMS activities and reporting, such as: ISO 13485/14971, FDA Regulations (21CFR (803, 806, 82, etc.)), CMDR, JPAL, Medical Devices Directive (93/42/eec, 98/79/EC)), and EU MDR is preferred
• Experience interacting with the FDA, ISO, and Other Regulatory Authorities preferred
• English proficiency oral and written .
  
  

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