Calling all Quality and Regulatory Compliance Specialists!!! Are you an experienced Compliance Specialist with experience of working in a medical devices industry? Do you have strong experience in creating Technical Files for CE marking approval? Do you have experience of the fulfilment requirements of IVDR and MDR, ISO 13485 and ISO9001? If so, please read on
The primary function of this role is to support the Quality and Regulatory Compliance function on a day-to-day basis to ensure coordination and compliance of Q&R activities across all areas of the business. A key element of this role will be focused on the co-ordination of Regulatory activities and across all areas of the business whilst supporting the management of Quality Management System. The Q&R Specialist will be expected to champion best practise of processes and contribute to the management and implementation of Q&R initiatives.
- Very competitive salary - dependent on experience
- 25+ bank holiday days
- Auto enrolment pension
- Free eye tests and flu jabs
- Free parking available
- To support the design, implementation and development of the Quality Management System
- Ensuring compliance with standards and legislation, particularly ISO13485, ISO9001, IVDR and MDR
- Experience of identifying non-conformances and implementing corrective and preventatives actions seeing them through to resolution
- Keep up to date with current regulatory industry standards and legislative updates (MDR, IVDR and UKCA)
- Establish and maintain the CE documentation to ensure that the products manufactured meet with the legislation in force.
- Administer the registration of CE devices to Eudamed / MHRA as required
- Producing medical device Technical Files and Device Master Files for CE marking approval
- Provide advice on packaging and labelling requirements, ensuring compliance with the directives.
- SOP review and maintenance to ensure procedures reflect current processes and ensure team members are kept updated and understand changes
- Support with supplier qualification ensuring a robust supplier approval process
- Carry out annual internal audits and participate in and external audits where required, supporting close out of non-conformances
- Ensure annual internal audit schedule is maintained and up to date
- Participate in third party audits with Regulatory authorities and Notified Bodies, supporting close out of any findings raised
- Support communication and training of changes to the Quality Management System processes to keep the business up to date.
- Strong experience in creating Technical Files for CE marking approval ensuring applicable requirements of IVDR and MDR and ISO 13485 are fulfilled
- Strong working knowledge of industry standards and regulations ISO 13485, IVDR, MDR and ISO 9001.
- Experience of maintaining compliance in a healthcare or medical device manufacturing environment
- Strong working knowledge with self-testing IVDRs, Class 1 and Class 2 medical devices
- To review new and existing MHRA / IVDR regulatory guidance documents, and assess the impact on our business
- Demonstrable experience in communicating with Regulatory Authorities, manufacturers, and suppliers
- Confidently use Excel/ reporting tools available to you in order to measure KPIs, areas of improvement, as well as analyse trends.
- Prioritisation of workload and well organised with task management.
- Confident in communicating with stakeholders at all levels
- Audit qualification preferable or willingness to work towards
- 3+ years of experience in a medical device industry
Interviews taking place next week, please apply today!
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