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

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

Experience with automated analysers
Experience with integration of assays to automatic analysers

Scientific knowledge and experience or working with healthcare products
Regulatory Affairs and / or Quality assurance background

19 Oct 2023

Libby Messitt

Scientific Recruiter 01494 818 018

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clinical diagnostics    ivd    hospitals