Beschreibung
We have an opportunity for an experienced Regulatory Affairs Expert to take charge of a project which is focused on conducting a GAP analysis on the existing regulatory technical documentation for registrations globally.Responsibilities
Assisting with reviewing of product and process documentation to ensure
compliance with change control requirements to aid determining if regulatory submissions are
required
Creation, review and maintenance of regulatory related technical documentation
Supporting team's daily operations of regulatory processes
Supporting maintenance of regulatory files and tracking databases to ensure prompt and
accurate access to company regulatory information concerning current, pending, and future
approvals and renewals
Providing progress of work-plans and the status of key project deliverables
Requirements:
Knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC
min 5 years of experience in European Medical device industry especially with regulatory, quality or engineering area
already gained experience in CE Marking and files registration
Please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.