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Senior Regulatory Affairs Manager - Manchester, City, M15 6SH

  • A hirdetés 1214 napja lejárt
Employment Type:Full TimeLocation:Manchester
Duration:PermanentFunctional Area:Regulatory Affairs

Position Description
Ensuring Compliance with global regulatory requirements
Taking overall responsibility as 'Regulatory Lead' for diagnostic device development projects i.e. strategy, regulatory risks
Participation in project teams to provide regulatory input into cross-departmental international registration projects
Preparation of documentation in order to support global regulatory submissions
Review and approval of labeling, advertising and promotional materials in order to ensure regulatory compliance
Supporting post-market activities (i.e. surveillance, vigilance, annual reports)

Position Requirements
Minimum degree (or equivalent) in a scientific field
Minimum of 5 years' experience in a similar role within the medical device industry, preferably in vitro diagnostics
Knowledge of the EU MDD and IVDD, US/Canadian medical device regulations and applicable standards

Personal Requirements
Good interpersonal skills and communication skills
Ability to handle multiple projects simultaneously
Ability to work with minimal supervision
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