Regulatory Affairs Manager (f/m)

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Regulatory Affairs Manager (f/m) & Regulatory Affairs Specialist (f/m) For our client, a market leader in the Medical Device industry, I am currently selecting Regulatory Affairs Experts who can support the RA department with product development activities.Responsibilities:Development and execution of regulatory strategies for assigned projectsResponsibility for all RA deliverables linked to the management of new product development activitiesSupport product registrations (CE marking, 510k and Canada submissions)Monitoring of submission timelinesCommunication with notified bodies or competent authoritiesCreation, review and approval of documents for the design control process; summary of technical documentationStrong cooperation with product development team to ensure compliance and timely market release of productsEnsuring that the company's products are compliant with the regulations of government agencies with a strong focus on the European Medical Device Regulations (MDR)Qualifications:Higher education (preferably engineering or science)Minimum of 5-10 years of experience in the Medical Device industryDeep knowledge of ISO 13485, 21 CFR 820, current EU MDR & MDDHas ideally already registration experience (EU, US and Canada)Preferably experience working with or for EU-MDR Authorities/EU-MDR commission or Notified BodiesPreferably experience with class III medical devices (but also class II device experience is sufficient)Excellent English skillsKey facts:Start Date: 04/2019Length: at least 1 yearWorkload: 100%Location: Central SwitzerlandAre you looking for a new challenge within Regulatory Affairs by working for an international, well-known medical device company? Then we are looking forward to receive your updated CV! Consultant Details:Elena Bollinger

T: +41 (0) 44 588 2619

E: e.bollinger(at)realstaffing.com Sthree Switzerland is acting as an Employment Business in relation to this vacancy.