We have a new project available for a regulatory affairs specialist who will support the regulatory affairs team for assigned project activities to comply with new MDR regulations.
Support preparation of technical documentation for submission to Notified Bodies, as required (both MDD and MDR) Provide regulatory support for New Project Development as assigned with focus on CE marking (under MDD as well as MDR) and US requirements (510(k)). Provide regulatory support for Life Cycle Management project Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned. Perform Regulatory Change assessments as assigned, Perform Labelling and Promotional Material Reviews as assigned.
Solid experience in Medical Device Industry and Regulatory Affairs. Understanding of MDR requirements and required content of Technical Documentation Understanding of the requirements of the current Council Directive 93/42/EEC Strong skills in MS Office (Excel, Access) for data analysisAbility to comprehend principles of engineering, physiology and medical device Strong analytical skills and proficiency in English.
This is 12 months contract role in Switzerland, extension may be possible.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.