Risk Management Specialist - Scenic Switzerland - High Tech products - English essential German a plus
Our client is a globally active medical devices manufacturer - in a leading market position, growing at unprecedented rate, and with continued demand during the Covidien crisis. Committed to ensuring that the Quality department grows in parallel, they are seeking a Risk Management specialist. This is urgent, a key role moving forward, and will be filled independent of any Covidien issues.
Their main responsibility will be the further development and implementation of ISO 14971 in the internal risk management process for the company's medical device products throughout their life cycle. In line with this also execution of GAP analyses, preparation of defect reports and training, and ensuring complete risk management documentation.
As such industry experience of at least 2 years is desired, working in Quality Assurance, Risk Management, or Regulatory Affairs within the Medical Devices sector is a Must. Regulatory Affairs experience is a further benefit as the work will require Regulatory support for the product throughout the life cycle, and communication with external testing bodies, thus ensuring European conformity
Experience in quality management, development, testing and production of medical devices is an advantage.
English is essential for this role, and being located in German speaking Switzerland, German very beneficial.
For more information on this vacancy, or any other QA opportunities within the Swiss Medical Devices sector, please contact the Senior Consultant Andrew Boroky on 0041 43 50 80 817, or email him at firstname.lastname@example.org together with scanned certifications of training and Arbeits Zeugnisse.
KEY WORDS: Regulatory Affairs, Risk Management, post market surveillance, Complaints, Switzerland, Quality Assurance, Compliance, CAPA, Medical Devices, German, English, 21 CFR 820, MDR, MDD, ISO 13485 / IEC 60601, ISO 14971, gap analysis, health authorities, testing bodies, notified body, Medical Device jobs, Nonstop recruitment, Manufacturing, Engineering
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