• Demonstrates collaborative patient and customer focus
• 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 must have adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate.
• Excellent communications and analytical skills
• Project management skills preferred
• In depth knowledge of medical terminology preferred
• Understanding of statistical fundamentals is preferred
• Experience with health hazard evaluations is preferred