Senior Regulatory Affairs Specialist - IVD

Radar Recruitment ,
Manchester, Greater Manchester
More Details
Salary: From £40,000 to £45,000 per annum + Benefits

Overview

We are currently supporting a multi-national and market leading business within the field of in-vitro diagnostics (IVD) to recruit a new Senior Regulatory Affairs Specialist to join their Quality and Regulatory team. The business: With a big focus on product development in recent years and expanding into new markets, this is a great opportunity to play a key role as part of a wider team that are at the forefront of their industry for years to come. This is a business that has invested heavily into attracting and retaining highly skilled people across different functions within their company, so you'll be working with a team of very capable professionals. The role and key responsibilities for the Senior Regulatory Affairs Specialist will involve: The core of this role will be key to supporting the overall regulatory affairs strategy within the company to ensure they are working towards their wider company goals. Key responsibilities will include: Involvement with IVDR planning transition within the company. Supporting post-market surveillance activity within the company. Responsible for creating and maintaining technical files as well as preparing regulatory dossiers and maintenance of import/product licences. Communicating key regulatory information across the business and being a contact to stakeholders at all levels within the company on key regulatory/technical issues. Managing relationships with regulatory agencies The ideal candidate for the Senior Regulatory Affairs Specialist will have the following background: Experience working in a Regulatory Affairs role within the field of In-Vitro Diagnostics (IVD) Good knowledge of IVD Regulations and Directives. Experience working with ISO 13485 standards. Degree or equivalent experience within life sciences field. This job was originally posted as www.totaljobs.com/job/89750902

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