Regulatory Affairs Specialist – Medical Devices
We have a new opportunity for a regulatory affairs expert with prior experience in medical devices to support the team in creation and maintenance of Technical Documentation for CE marked products (implants and instruments) according to Council Directive 92/42/EEC and Medical Device Regulation 2017/745.
Creation of Technical File Summary Reports, Reviewing of and providing input for Clinical Evaluation Reports, Risk Management, Labeling
Creating and Maintaining of data sets that support Technical Documentation creation, maintenance and sustainability
Support registration activities in countries, EMEA, APAC, LAT and US
Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC and Medical Device Regulation 2017/745
experience in European Medical device Industry especially within regulatory, labeling, quality or engineering.
Familiarity with Technical Documentation structure according to STED and as required by Medical Device Regulation 2017/745
experience with PLM systems such as Windchill PLM, Agile e6 PLM, Technically versed in computer software such as MS Word, Powerpoint.
Strong skills in MS Excel essential
Strong database skills (Access, SQL) desired
This is 2 years long contract , please send your CV
Michael Bailey International is acting as an Employment Business in relation to this vacancy.