This company is developing innovative molecular diagnostics products, combining software and reagents, for the International clinical market. They specialise in the use of cell free DNA to inform clinical decisions with a particular focus on post-treatment cancer surveillance via liquid biopsy.
They are looking for a Senior Regulatory Affairs Specialist to join their site in Birmingham. The main focus of this role will be to support the company's regulatory responsibility for the genomic IVD product applicable regulations, standards and country specific requirements, to enable and support the commercial registrations strategy for market access.
The position requires excellent IVD regulatory knowledge and communication skills, to support internal and external customers, support for business process improvements with sound knowledge of ISO13485, including regulatory submissions controls, full compliance for regulatory and quality related activities to the latest state of the art Global Regulatory requirements.
- Liaise with the company leads to plan, manage and execute regulatory activities for the commercial global mapping/delivery of certified products and ongoing maintenance support
- Conversant with and ability to apply MDR2002, IVDD 98/79/EC, MDD Directive 93/42/EC, MDR 2017/745, IVDR 2017/746MDSAP country requirements IEC62304 and QMS ISO13485, including CE-marking activities.
- Creation, management and maintenance of Technical Files / Medical Device Files - Genomic product lines and software
- Prepare regulatory dossiers, for product license applications/maintenance with regulatory authorities
- Manage relationships and have excellent communication skills working with regulatory agencies / authorised representatives and also when sharing regulatory data/information to the internal teams
- Hands on approach to assessing impact of new and updated regulatory requirements and planning to cover the key change controls with internal and external stakeholders.
- Support the regulatory requirements for New Product Development process, contributing to product validation plans, reports, product technical claim support papers and post market planning.
As the ideal candidate, you will have at least 5 years' experience in Regulatory Affairs within IVD, diagnostics and/or life sciences on top of a life science degree. You will have experience with global registrations, submissions, IVDD/IVDR, FDA and ISO 13485. You will be proactive and be able to work well under pressure.
Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.
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