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Quality & Regulatory Manager

Essex - Harlow
up to £60000 per annum
Job Reference

Our bespoke client a market leader in Medical Devices based within Harlow CM20 /M11/ A10 road network are now looking to employ a Quality and Regulatory Affairs Manager to join their business on a permanent contract.

As the Quality and Regulatory Affairs Manager, you'll be reporting directly into the Operations Director. You will be expected to work with the internal manufacturing plants plus the wider supply chain to ensure that all products are supplied to the correct standards maintaining the compliance and effectiveness of the Business Quality Management System (BQMS) of the company...

Ideally you'll have a life sciences degree in management/manufacturing/law or equivalent (desirable). You must also have a working knowledge of ISO 9001 and ISO 13485, MDD and MDR)

Responsibilities & Authorities:

  • To take responsibility for, and ensure employee compliance to, all company and legislative Health & Safety and environmental requirements within the department. Planning the Quality & Regulatory strategies of the company

  • Provide leadership to QA/QC/Regulatory team

  • Main responsible in managing and maintaining compliance with the applicable medical device regulations e.g. MDD 93/42/EEC (migration to MDR), US FDA 21 820 QSR, CFDA No. 650

  • Main responsible in managing and maintaining conformance with ISO 9001 and ISO 13485 certifications

  • Act as the main contact person in liaison with the national competent authorities and notified body

  • Managing the application and/or renewal of product registration and license

  • Hosting management review meetings and report to senior management the overall performance of the Business Quality Management System (BQMS)

  • Hosting of client/3rd party audits, and managing any non-conformances to satisfactory outcome

  • Management and submission of technical files for manufactured medical products

  • Providing quality/regulatory input in the NPD/EPD process

  • Managing the internal audit program and provide support to pool of auditors

  • Leading/assisting the investigation of quality issues, customer complaints or product failure

  • Ensure that periodic reviews of procedures are completed by process owners to ensure effectiveness of the processes is maintained

  • Reviewing and approval of product labelling and marketing materials to ensure compliance with the applicable regulatory requirements

  • Provide full regulatory support to export markets as required

  • Ensuring all processes needed for BQMS are documented and controlled

  • Reporting to LTM on the effectiveness of the BQMS and any needed improvements

  • Promoting awareness of applicable regulatory BQMS requirements throughout the organisation.

Knowledge & Experience:

  • Relevant experience in a QA Management position in a manufacturing-based SME environment within a regulated industry (medical device / drug or other suitable industries)

  • Knowledge of Medical Device Regulations (EU/Global) is essential

  • Knowledge of international/harmonised standards, such as, ISO13485, ISO9001, ISO 14971, ISO14001 HSE 18000

  • Relevant degree in management/manufacturing/law or equivalent (desirable)

  • Experience in generating comprehensive and effective reports

  • Experience in process control improvement projects & in QMS and supplier audits/development

Please apply by CV showing your capability to review, analyse, summarise and interpret quality systems data, draw conclusions, make appropriate decisions , key recommendations, write complex reports , maintaining and developing best practices .


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