Senior Regulatory Affairs Specialist - Medical Device Industry

SolothurnTemporaryChemistry, Pharma, Biotech2019-04-23Bachelor / University of Applied Sciences
On behalf of our client, an international Medical Device company, we are looking for an experienced Regulatory Affairs Specialist with experience in Medical Device Industry and Regulatory Affairs.

Senior Regulatory Affairs Specialist - Medical Device Industry

Your challenges


Support local franchise Regulatory team for various activities in conjunction with MDR compliance work.

•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 as instructed and assigned.
•Perform Regulatory Change assessments as assigned.
•Perform Labeling and Promotional Material Reviews as assigned.

Your skills


•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
•Previous experience within Regulatory Affairs at in Med-Tech preferred
•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 and proficiency in English written and spoken.
•German in addition would be an asset.

Your contact

Lisa Bianculli, Recruitment Consultant, looks forward to answer your questions by phone +41 58 233 2102 or eMail.

You can apply directly online, or by eMail. Please mention reference in your application