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Quality & Regulatory Manager - £45 - 55k pa

Job Reference: 10539-CC

Contract type:
Full Time

Duration:
Permanent

Location: Surrey

Kinetica is delighted to be recruiting a Quality & Regulatory Manager on behalf of a world-renowned healthcare organisation.

The appointed Quality & Regulatory Manager will be responsible for implementing and coordinating the company’s response to ISO 9001, 98/79/EC In Vitro Diagnostic Medical Devices (IVDD), 93/42/EEC Medical Device Directive (MDD) and global Quality Regulations. Additional responsibilities will include:

  • Work to deploy and maintain an audit programme for ISO9001 certification
  • Ensure compliance of customer oriented managed service solutions
  • Manage external certification audits and coordinate of improvement actions associated with findings
  • Deploy an effective vigilance programme for IVD products and reagents

The Requirements

  • Experience of managing an ISO9001 certified management system in a medical device environment
  • Understanding of product safety principles Detailed understanding of ISO9001
  • Degree educated in a relevant subject
  • Ability to coordinate operations to ensure compliance with certifications, directives and internal quality regulations
  • Strong influencing, negotiation and communication skills
  • Excellent problem solving ability
  • Demonstrable leadership qualities
  • Experience working in IVD industry
Apply Now

Claire Collinson
e-mail: info@kinetica.co.uk
Telephone: 0113 2617181

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