Beschreibung
We have a new project to support new product development area and we are looking for an RA manager with strong skills and experience in technical documentation and dossier management.Main activities include:
Support preparation of technical documentation or design dossier documentation for submission to and review by Notified Bodies, as required (both MDD and MDR) as assigned
Support compliance execution work in collaboration with local Regulatory Team.
Provide regulatory support
Requirements:
At least 5 years of experience in Medical Device Industry and Regulatory Affairs.
Understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) )
Understanding of requirements of current Council Directive 93/42/EEC
Experience with creation and maintenance of Technical Documentation in PLM Systems preferred
Experience in IT system documentation and database management preferred
Experienced skills in MS Office (Excel, Access) for data analyses and comparisons
Ability to comprehend principles of engineering, physiology and medical device use.
Strong analytical skills and proficiency in English written and spoken.
This is a contract till end of they year with possibility for extension.
Please contact Beata Klecz on
Michael Bailey International is acting as an Employment Business in relation to this vacancy.