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Quality & Regulatory Manager

Job description

Our client, based in Banbury, is one of the UK’s fastest-growing Medical and Scientific Distribution Companies with plans to double the business within the next three years. Due to continued growth, they are now looking to hire an experienced Quality & Regulatory Manager to join their experienced team. This is a hands-on role with direct responsibility for developing, implementing and enforcing quality management procedures and systems. Maintain compliance and timely registration for licensing and products associated with the business. Identify compliance issues that require follow-up and conduct internal investigations of compliance issues with the aim of continuously looking for process improvements and ruling out non-compliance issues. Fully responsible for application, monitoring and process management of multiple ISO certificates and licenses vital to the business.

Main Duties & Responsibilities:
  • Implementation and Management of the quality system deployed within the company.
  • Responsible for all ISO management & audit including 9001 and 14001
  • Ensuring adherence to the requirements of the Company’s Wholesaling Distribution Authorisation
  • Ensuring compliance with the requirements of Good Distribution Practice (GDP).
  • Fostering a commercially orientated quality-driven culture across the company.
  • Ensuring that all staff members are trained in the duties assigned to them and refresher training provided as appropriate.
  • Management of the Product Recall Procedure.
  • Management of CAPA’s and customer complaints.
  • Approval of all suppliers, subcontractors and customers.
  • Implementation and Management of self-inspection schedule.
  • Management of the final disposition of all returned, rejected, recalled or falsified products.
  • Monitoring changes and enhancements to quality/quality standard-related regulations and how they may affect the company’s operations and ensuring the company is in adherence with such regulations.
  • Approval of any product returns to saleable stock.
  • Participation in management meetings.
  • Adherence to standard operating procedures in use in the company.
  • Liaison with external regulatory bodies on all quality and regulatory-related matters.
Previous Experience/Qualifications:
  • The ideal candidate would have experience with medical devices.
  • Quality/Regulatory qualification
  • Working knowledge of ISO certification – 9001 and 14001
  • Previous UKAS experience for calibration.
  • Effective communication and report writing skills.
  • Good negotiation skills with a customer-oriented attitude.
  • Excellent analytical abilities to grasp the key points from complicated details.
  • Good leadership capabilities to lead projects to successful completion.
  • Basic knowledge of applicable software to infer statistical data.
  • Familiarity with the tools, concepts and methodologies of quality management
Additional Information:
  • Please note this is a full-time, permanent role working Monday – Friday 9 am – 5 pm with hybrid working available.
  • Performance bonus incentive
  • Opportunities for career advancement and professional development.
  • Dynamic and collaborative work environment with a focus on innovation and excellence. 
Please contact Matt Hartwell on 07301283663 or email your CV to matt.hartwell@forcerecruitment.com for a confidential chat.