Work SiteSwitzerland / | CHE - All Regions / Basel
Contract TypePermanent [Full-Time]
Minimum number of years of experience required5 years of experience and more
Our offer
A permanent contract with the leader in innovation and high-tech engineering consulting
A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR. 3.3 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).
In Switzerland, Altran employs more than 300 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.
Your role
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
Provide regulatory support for Life Cycle Management projects as assigned
Manage data cleansing and comparison, remediation and maintenance of existing
Technical File documentation as instructed and assigned.
Perform Regulatory reviews for Labeling and Promotional Material of CE marked devices
Perform Regulatory Change assessments as assigned
Support compliance execution work in collaboration with local Regulatory Team.
Your profile
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) 2017/745)
Understanding of requirements of current Council Directive 93/42/EEC
Previous experience within Regulatory Affairs is preferred
Experience with creation and maintenance of Technical Documentation in PLM Systems preferred
Experience in IT system documentation and database management preferred
Ability to comprehend principles of engineering, physiology and medical device use.
Strong analytical skills and proficiency in English written and spoken. German in addition, would be an asset.
