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Regulatory Affairs Consultant (home based) job in West Bridgford at RQM

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Regulatory Affairs Consultant (home based) at RQM

Regulatory Affairs Consultant (home based)

RQM Nottingham, Nottinghamshire, Nottinghamshire Full Time
£45 - £70/Hour
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RA Consultant

Role

•Creation, development and maintenance of high quality regulatory compliant documentation for EU market specifically the EU technical files to MDD

•Review and update the technical file documentation liaising with subject matter experts including change owner, production, labelling, clinical, product quality engineering and quality

•Provide updates to the regulatory and change control team on progress

•Work with the change control team to understand priorities and complete tasks on time in full

•Complete any registration activities in international markets working with the client regional team

Skill Set

•Experience with MDD to MDR remediation projects for medical devices

•Experience with Technical writing and reviewing technical documents

•Knowledge of design and risk control processes within a Medical Device Company QMS

•Experience in reviewing sterilisation and biocompatibility documents for medical devices would be an advantage

•Excellent organisation and communication skills required

•Must be able to work off own initiative and be solution focused
 

Recommended Skills

Technical Writings
Biocompatibility
Documentation
Engineering
Model Driven Development
Medical Device Directive

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Job ID: 214036021

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