job details posted 22. November 2018 location solothurn sector Life Sciences job type temporary reference number 11987 contact lucie nasshan, basel professionals health care & life sciences phone 058 201 55 50 apply now email job description Randstad Professionals is currently looking for a Senior Regulatory Affairs Specialist in Medical Devices who will be assigned an interesting challenge for a major client based in Solothurn. This contract is a great opportunity to join a major client, global group focusing on the Healthcare sector (Medical device, Pharma/vaccines, Consumer health). The initial assignment will start ASAP ( december 2018) and will last until December 2019. Your role will be to support local franchise Regulatory team for various activities in conjunction with MDR compliance work. Tasks: Support preparation of technical documentation or design dossier documentation for submission to and review by Notified Bodies, as required (both MDD and MDR) Provide regulatory support for New Project Development projects 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 as assigned Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation Perform Regulatory Change assessments Perform Labeling and Promotional Material Reviews Candidates’s profile : At least 4 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 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 Proficiency in English written and spoken. German in addition, would be an asset. share: Facebook LinkedIn Twitter Xing