Regulatory Affairs Specialist

For a permanent position, Proffice Life Science is looking for a Senior Regulatory Affaires Manager for a successful and well known medical device company in the Gothenburg area.The Senior Regulatory Affairs Managers' position is responsible for daily regulatory activities in the Gothenburg office and collaborates closely with the global Regulatory Affairs department.The position helps develop EU and Eastern European EU strategies/analysis to be integrated in the global regulatory plan.The position ensures that agreed strategies are converted into daily business for the department.This position is key in maintaining Technical Files for compliance with the EU Medical Device Directive (current and as amended) and in coordinating registration activities in Eastern Europe.Good interaction with the local/global Q&A department in aligning strategies/daily business is of utmost importance, as well as working in matrix organisation.The right candidate for this position has a minimum of five years of experience within the medical device regulatory affairs including CE marking.You are a good communicator and your skills in English are excellent orally as well as in writing.A second language is adventageous.You also have a university degree.You are a good organizer and a teamplayer who easily colaborates with your colleagues on all levels and are used to working internationally.You must be able to travel.Please apply for this position at www.proffice.se.