Regulatory Affairs Specialist - IVD / ISO13485

Job Description

Are you a Regulatory Affairs Specialist looking for a new exciting job opportunityWe are currently looking for a Regulatory Affairs Specialist to join a leading diagnostics company based in the Manchester area. As the Regulatory Affairs Specialist you will be supporting the RA team according to the organisations regulatory affairs strategy, in order to fulfil the companys global commercial strategy. The role requires understanding of the current IVD regulatory framework and processes, in order to progress documentation, to primarily support regional submissions and maintenance of CE-IVD/Regional dossiers.KEY DUTIES AND RESPONSIBILITIES:Your duties as the Regulatory Affairs Specialist will be varied however the key duties and responsibilities are as follows:1. You will be responsible for the maintenance of Technical Documentation Files for the companys device range in accordance with the requirements of the IVDD 98/79/EC and IVDR (EU) 2017/746 for CE-marking activities.2. Administrate regulatory dossiers to support product license applications, import license and product license maintenance for worldwide Regulatory Authorities. You will also be responsible for maintaining specialist knowledge and tracking of the regulatoryrequirements within each of operational geographical territories.3. Additionally, you will also support the development of the companies regulatory planning, incorporating strategies for the product range in accordance with global requirements as well as support product risk management activities and the life-cycle of marketedproducts.4. Support the regulatory requirements of the product development process, contributing to product validation plans, reports, claim support papers and other post market activities. Conduct all duties in compliance with GMP, ISO13485, ISO9001, GCP and otherregulatory requirements as identified.ROLE REQUIREMENTS:To be successful in your application to this exciting opportunity as the Regulatory Affairs Specialist we are looking to identify the following on your profile and past history:1. Relevant Life Science or equivalent degree such as in genetics or molecular biology.2. Proven industry experience working within a regulatory affairs position. You will need to have experience working in the medical devices / IVD sector and have good knowledge of ISO 13485 and IVD RA requirements.3. A working knowledge and experience of product registration is required. The ideal candidate will have Global RA experience. Key Words: Regulatory Affairs Specialist | Medical Devices | IVD | in vitro diagnostics | Molecular Biology | Genetics | Healthcare | Pharmaceutical | Life ScienceHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS isa company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.