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 of 8. 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 the US, Canada, and Europe.
- Lead all FDA and ISO 13485 audits
- Work with a team on new product development projects and implement proper quality control procedures.
- The 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.