Regulatory Specialist

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Regulatory Affairs Specialist (f/m/d)For our client, a market leader in the Medical Device industry, I am currently selecting Regulatory Affairs Specialist who can support with the development and execution of regulatory strategies.Key facts:Start Date: immediatelyLength: 6 monthsWorkload: 100%Location: Central SwitzerlandTasks:Creation, review and/or approval and maintenance of technical files, significant notifications, Canadian registrations and US 510(k) submissions. Further submission and review interactions with notified body, Health Canada and FDA.Development and execution of regulatory strategies for development projects, product change projects, and lifecycle management activities.Provide regulatory guidance and strategic planning in projects related to compliance EU, US & CA, under some guidance and supervision.Ensuring timely maintenance activities for EU, US & CA including ECOs, STEDs, GSPRCs Knowledge, skills & ExperienceMin. 4 years experience in medical devices with good experience in regulatory affairsVery good knowledge of EU, US, and CA medical device regulationKnowledge of design control process requirements and requirements for technical documentation for medical devices. Knowledge in requirements and processes for CE, US and CA submissionsKnowledge of medical device quality management systems 21 CFR Part 820 and ISO 13485Quality and design assurance experience is an advantageHands-on and communicativeAbility to work in an international matrix organizationProject management skillsFluency in English / German is an advantageSthree Switzerland is acting as an Employment Business in relation to this vacancy.