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Head of Quality Assurance & Regulatory Affairs - Excellent Salary Package

Job Reference: 10712-CC

Contract type:
Full Time


Location: Coventry, West Midlands

Our client develops and manufactures an array of products used within the healthcare industry, and has recently selected Kinetica to lead its search for a Head of Quality Assurance (QA) & Regulatory Affairs.

The appointed candidate will be responsible for developing, implementing, maintaining and promoting a Quality Assurance and Regulatory Affairs strategy. You will provide leadership to the Quality Management System team and ensure compliance to all applicable standards, regulations and internal procedures. Additional responsibilities of your role as Head of Quality Assurance & Regulatory Affairs will include:

  • Prepare regulatory strategies to support the registration of new and existing products
  • Manage communication with customers, suppliers and regulatory bodies to address issues and accreditations
  • Develop, implement and support management of quality assurance related projects
  • Promote continuous improvement
  • Provide Quality Assurance and Regulatory expertise

The Requirements

  • Strong experience within Regulatory Affairs
  • Good experience of Quality Assurance in a Medical Device or IVD Environment
  • Demonstrable experience of applying ISO 13485, FDA 820 part 21 and MDD standards and regulations
  • Proven success in negotiating with regulatory bodies, customers and suppliers
  • Significant experience of preparation of 510(k) submissions, CE Mark Technical files and Design Dossiers and Canadian MDL
  • Clean room and GMP knowledge / experience
Apply Now

Claire Collinson
Telephone: 0113 2617181

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