Regulatory Affairs Specialist - medical devices

Description

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 .

Tasks:

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

Requirements:

Profound knowledge of European Medical Device Regulations, especially Council Directive 93/42/EEC and Medical Device Regulation
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
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.