Regulatory Affairs and Quality Assurance Manager

Our client is a global leader manufacturing a wide range of consumer products. Their Healthcare Division has an immediate need for a Regulatory Affairs and Quality Assurance Manager.
Report to the Director and manage a staff responsible for quality control testing, running trials and handling all documentation and reporting.
Oversee quality system compliant with FDA and ISO 13485 standards 
Responsible for understanding all global regulations concerning medical products including US, Canada and Europe.
Lead all FDA and ISO audits 
Work with a team on new product development projects and implement proper quality control procedures 

Requirements:

• Ability to lead both FDA and ISO audits is a must.
• Bachelor's Degree is required. 
• Must have at least 4 years of quality assurance experience including some management experience.   
• Any type of medical device manufacturing experience will be considered.