Quality Assurance/ Regulatory Affairs Manager, Medical Devices
Location: Liverpool/ site based
Hours: (Monday - Friday) 9:00 - 17:00
Additional: 23 days + BH, Life assurance, Private Health Cover, Bonus, 3/5% Pension, Parking onsite
Russell Taylor Group is working exclusively with one of our amazing Medical Devices Clients on this position; our client is part of a global group of Medical Devices companies. The current role-holder is retiring, and we are looking for an experienced QA/RA Manager to manage all related quality function/s, QMS and QA/RA staff (x6 members).
Reporting the Technical Director, the QA/ RA Manager will:
- Maintaining compliance with applicable standards (IVD. IVDR) and statutory regulatory requirements necessary for the continued business activities of Clients relating to products developed, manufactured, and sold by Client.
- Ensuring the systematic working of all applicable standards together with the management, measurement and monitoring of processes (e.g., Product management, complaints, audit, improvement, corrective, and preventive actions).
- To ensure all documentation relating to regulatory issues relating compliance product registration, shipping etc. are in place and available as required.
- To act as the Management with responsibility and authority in accordance with the requirements specified in ISO 13485:2016.
- To ensure compliance with the requirements of Client's QMS to ISO 13485 and ISO 9001.
- Responsible for identifying and ensuring compliance as far as practically possible with all applicable UK, EU and worldwide standards, regulations, and directives in relation to the development, manufacture and sale of IVD Medical Devices.
- To manage a team of staff (QARA team) with responsibility for the day-to-day activities of QA provision and promotion within Client and applicable regulatory affairs activities (x6 direct reports).
- To ensure that activities such as audits, CAPAs etc are carried out at an excellent standard to help prevent error.
- Mentor and train staff as required in areas such change control, document writing and control, auditing, and relevant standards. Updating training records and staff matrices when required.
- Revision of the Quality manual and policy to maintain correct, relevant, and current Quality System documentation at all times.
- Act as the Chairperson at the Clients' Management Review Meetings (held very 8 weeks). This is to ensure that the key elements relating to the review Input and Output as required by ISO 13485 are reported and reviewed.
- Ensuring that the company wide document control system/s are effective and fit for purpose. For example, issuing documents for change, new document numbers and reviewing the content, style, and accuracy etc.
- Oversee the incident reporting systems within the company along with the QARA team.
- Responsible for management, training and planning of the internal audit programme and conducting internal audits.
- Ensuring equipment used for measuring and monitoring purposes are specified and calibrated.
- Verifying all new suppliers and for QA approval of new suppliers and quality assess the suppliers.
- Ensure customer complaints are logged and investigated in accordance with client procedures and within a timely manner and in accordance with KPIs.
- To work with the QC Manager and members of the QARA team to ensure relevant procedures and practices are put in place to ensure compliance with the requirements of ISO 17025 for specific product groups.
- In conjunction with the R&D staff, ensure that for all new products or when significant changes are made to existing products, are developed in compliance with current quality and regulatory standards. To be involved with regular new product team meetings to advice on QA, documentary, and product technical file requirements
- Be a member of the British in Vitro Diagnostic Association (BIVDA) Regulatory Affairs Working Party meeting to ensure Client is kept informed of new standards and changes
- The QARA Manager in conjunction with the QARA team shall ensure that all product labels, Instructions for Use (IFUs) and product packaging are maintained in accordance with all relevant national regulatory requirements.
- Will hold a Degree in a Scientific discipline (ideally Microbiology based)
- Previous QA/ RA Management experience in a Medical Device setting with experience in:
- ISO 13485, UKAS 17025, ISO 9001, IVD/MDR regulations / QMS implementation and QMS management
- Previous line management/ supervisor experience in a Medical Devices - QA/RA role.
- Experience in external/ internal auditing
- Experience in raising CAPAs and extended QA activities (Change Control/s, OOs, OOt, Deviations) and RA activities (document control systems, product label checks, SDS write ups etc).
- We are looking for someone who can manage change, who will constantly keep abreast of the latest regulations (MDR, IVDR etc).
- Strong interpersonal and project management skills required.
- We want someone who can influence change and who can lease with key stakeholders alongside mentoring relatively new QA/RA staff.