£Contact Libby
Remoto
Las relaciones de larga data
Zenopa desarrollar fuertes relaciones de trabajo con nuestros clientes, lo que significa que comprendemos su empresa y los valores culturales.
The role is covered in the following locations: Birmingham, Bath, Brighton, Bristol, Belfast, Cambridge, Cardiff, Derby, Edinburgh, Glasgow, Guildford, Liverpool, Leicester, Leeds, Manchester, Newcastle-upon-Tyne, Nottingham, Oxford, Portsmouth, Reading, Sheffield, Swindon, Southampton, Tonbridge, London, York
Key Duties and Responsibilities
To organise and manage projects as part of new product development regulatory affairs team for in vitro diagnostics product range for sale in global markets.Represent company for 3rd party submissions for FDA, Notified Bodies and global regulatory authorities
Support key development projects to meet strategic business objectives
Manage global submissions including EU, FDA
Represent RA in product development projects
Provide leadership and guidance on regulatory issues and ensure regulatory requirements are well understood and communicated
Support Internal audits
Represent RA in 3rd party audits - MDSAP, FDA
Working Environment - Remote
Some international travel will be required
Person Specification
Education:B.Sc. in Life sciences
Desirable: M.Sc. or higher in life sciences
Knowledge and Experience:
Several years in design and development of in-vitro diagnostic medical devices
4+ years working in cGMP or regulated environment compliant with ISO13485, 21 CFR part 820 or equivalent
Experience of working teams in a regulated industry
Experience of leading teams or projects in a regulated industry
FDA submissions experience for 510k, and presubmissions
Desirable:
Experience with automated analysers
Experience with integration of assays to automatic analysers
Skills
Scientific knowledge and experience or working with healthcare products
Regulatory Affairs and / or Quality assurance background
Apply for this role
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