Regulatory Affairs Specialist


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

27th October 2020

Location

Switzerland

Salary/Rate

£83 - £84

Type

Contract

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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: 11/2020Length: 9 monthsWorkload: 100%Location: Central SwitzerlandTasks:Support of RA processes related to imported/distributed products (=3rd party legal manufacturer products) for CE, US and CA.Support development and execution of regulatory strategies for development projects of distributed products, product change projects, compliance projects and lifecycle management activities.Execution of lifecycle management activities related to distributed products (change management, implementation of MDR obligations as distributor/importer, supply chain analysis)Ensure completion registration/notifications in local EU registersProvide regulatory guidance in projects related to distributed products under guidance and supervisionAssessment of compliance status to applicable regulations (i.e. EU, US, CA) of distributed productsReview and approval of product related labeling, IFUs and marketing material and associated claims under guidance and supervision Knowledge, skills & ExperienceMin. of 2 years of experience in medical devices with good experience in regulatory affairsVery good knowledge of new EU MDR, good knowledge of EU, US, and CA medical device regulationExperience in reviewing, interpreting changed legislation and implementing it successfully in processes and procedures. Understanding of general medical device supply chain specifics and operational distribution network requirementsUnderstanding of contractual agreements related to supply chain (distribution agreements, quality/regulatory agreements between manufacturer and distributor)Knowledge of design control process requirements and requirements for technical documentation for medical devices. Knowledge in documentation requirements and processes for CE, US and CA submissionsKnowledge of medical device quality management systems 21 CFR Part 820 and ISO 13485Knowledge of quality and regulatory systems and processes from a system perspective.Hands-on and communicativeAbility to work in an international matrix organizationProject management skillsFluency in English / German is an advantageKnowledge of SAP including systems understanding data handling and office based systems, especially Excel Sthree Switzerland is acting as an Employment Business in relation to this vacancy.

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