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Head of Quality and Regulatory Expert

4 weeks ago

Manchester, United Kingdom Michael Page Full time

As a seasoned Head of Quality and Regulatory, you will be responsible for leading a team that ensures the highest standards of quality and compliance in a global manufacturing company. Based in Manchester, this senior management role requires a strong background in quality management systems, regulatory affairs, and team leadership.

Key Responsibilities:
  • Develop and maintain robust quality management systems to ensure statutory and contractual duties are fulfilled.
  • Provide clear regulatory advice and guidance to the organisation, and design and execute regulatory strategies.
  • Support and represent the Quality & Regulatory discipline in new product introduction and product development projects.
  • Oversight of internal and external compliance activities to ensure the organisation is compliant and prepared for audits.
  • Undertake due diligence to validate and approve new suppliers and manage ongoing requirements and audits.
  • Maintain current and create new ISO documentation for each site, increasing scope of certification as necessary.
  • Manage relationships with key Certification Bodies for ISO Management System Audits, Product Testing, and Certification.
  • Responsible for the internal lab and ensuring in-house compliance testing is completed on an ongoing basis.
  • Collate data for technical files, including clinical evaluations, risk assessments, and other items.
  • Collate data for the management review for ISO13485.
  • Involved in customer complaints relating to non-conforming product and ensure timely resolution and corrective action.
  • Provide escalation, weekly updates, and reports to line managers and wider management as required.
  • Takes personal responsibility for notification and tracking of Regulatory and quality activities and related database entry/data accuracy.
  • Highlights updates to regulatory requirements to senior management.
  • Maintains the calibration register for testing and measuring equipment.
Requirements:
  • Experience in a manufacturing environment, preferably in a highly regulated or safety-critical sector.
  • Working knowledge of ISO9001 and MDD/MDR.
  • Experience working with Class 1 and Class 2a (sterile) Medical devices.
  • Internal audit qualification for ISO9001 (minimum).
  • Knowledge of other standards such as ISO14001, ISO45001, and ISO13485 would be an advantage.
What We Offer:

A competitive salary of £70,000 to £90,000 plus package, and the opportunity to work with a well-established global manufacturing company.