Regulatory Affairs and Quality Assurance Manager

Regulatory Affairs and Quality Assurance Manager

Newburyport, MA

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.

Requirements:

• 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.