Senior Regulatory Affairs Specialist

Unimed Consulting Limited ,
Manchester, Greater Manchester
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Overview

A fantastic opportunity has arisen to join a Global Healthcare Manufacturing Organisation as a senior Regulatory Affairs Specialist. This role will help support effective management of the organisation’s regulatory affairs strategy, in order to support and fulfil the company’s global commercial strategy. The role requires a level of management and liaison with internal team functions, regulatory authorities. The Role The creation, management and maintenance of Technical Files for the product range in accordance with the requirements of the IVDD 98/79/EC and MDD Directive 93/42/EC, including CE-marking activities. Involvement with the IVDR planning transition for the business. Experience of country registration processes for worldwide commercial support Prepare regulatory dossiers to support product license applications, import license and product license maintenance for worldwide Regulatory Authorities. Proactively manage relationships and communications with regulatory agencies and authorised representatives. Maintain specialist personal knowledge of the regulatory requirements within each of operational geographical territories. Collate, interpret and disseminate specialised regulatory information across the business. Support for the development of the company’s regulatory plan, incorporating strategies for the product range in accordance with global requirements. Monitor the regulatory environment, assessing the impact of new or changing regulations to the business. Develop transitional plans, as required, to ensure the business continues to operate to current and future regulatory requirements. Support product risk management activities and the life cycle of marketed products. Support for the post market surveillance, preparing reports for the product range, annually. The ideal candidate will have Degree in a life science or equivalent either in genetics or molecular biology and significant experience working within a regulatory affairs arena. Knowledge of ISO 13485 and IVD Directive requirements. Excellent organisational skills and an ability to work to tight timelines. Demonstrate strong team skills. The Business: A growing, multi-national business with a track record of delivering the highest quality products to a prestigious client base Focused on achieving growth alongside an efficient and productive environment. Worldwide leader in healthcare development and commercialisation. Interviews are to be held shortly, and suitable candidates will be contacted within 24 hours of application. To apply for the role, please send your CV and salary details to Unimed Consulting using the ‘Apply Now’ button. If you would like to have a confidential discussion on the role, you can contact the Consultant, (Tarnya Sharp) quoting the job reference number (TSSRA01) Unimed Consulting: Our technical and scientific recruitment brand is well respected for the high quality of work we have delivered for both clients and candidates. Our in-depth knowledge of recruitment across the Healthcare sector enables us to provide advice based on experience and to give you the best access to client vacancies . This job was originally posted as www.totaljobs.com/job/89754255

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