QARA Manager - Swiss MedTech-English essential

Quality Management and Regulatory Affairs Manager - Swiss MedTech - English essential, French desirable

Today I am working with a young Swiss Med Tech located in French speaking Switzerland, and specialising in IT/ Software applications for both Medical device and Pharmaceutical sectors. With a road map for the next 2-3 years they are seeking a QARA Manager to take on overall responsibility for development and maintenance of the QMS, site certification and upgrades to ISO 13485, internal and external audits, communication with health authorities, while supporting the Regulatory Affairs department in defining and implementing the regulatory pathway for approval of products in Europe (MDR) and the US (FDA), and with involvement in the preparation and submission of dossiers is important.

A useful background would be a Degree/Diploma in the Life Sciences, Engineering, or IT, with a number of years industry experience in Quality and Regulatory Affairs within the Medical Devices sector: ISO 9001, ISO 13485, MDD, and MDR. Ideal background would be someone who came from a software development background within Medical devices and working specifically to ISO 62304, who then moved into quality thereafter.

The position is permanent and with very good flexibility in working hours and home based work, partly to minimise any impact of Covid to employees, and partly because of the time zone differences in communicating with US based clients. If this sounds like it is you, then please apply today to the Senior Consultant Andrew Boroky on 0041 43 50 80 817, or email him at a.boroky@nonstopconsulting.com together with scanned certifications of training and Arbeits Zeugnisse.

KEY WORDS: QMS, Quality Management System, Germany, Switzerland, Quality Assurance, Risk Management, Compliance, CAPA, Medical Devices, electrical, mechanical, software, French, German, ISO 13485, ISO 60601, ISO 62304, MDR, Regulatory Affairs, Registration, Competent Authority, Notified Body, Medical Device jobs, Nonstop recruitment, Manufacturing, Engineering

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