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.Implementation and Management of the quality system deployed within the company.Responsible for all ISO management & audit including 9001 and 14001Ensuring 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.Participation in management meetings.Liaison with external regulatory bodies on all quality and regulatory-related matters.
The ideal candidate would have experience with medical devices.Quality/Regulatory qualificationEffective communication and report writing skills.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
Please note this is a full-time, permanent role working Monday – Friday 9 am – 5 pm with hybrid working available.Performance bonus incentiveOpportunities for career advancement and professional development.com for a confidential chat….