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Regulatory Affairs and Quality Assurance Manager

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Coley Company

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.
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