Jonathan Wirtz
Interim Head of Product Regulatory at Vivalyx
Based in Simmerath, Germany
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Seniority
Director
Department
General Business & Management
Location
Simmerath
Industry
Medical Equipment Manufacturing
Company size
17
Contact information
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j•••••••@vivalyx.com
Phone
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Background
About Jonathan Wirtz
I worked for three years as a consultant for a renowned company in southern Germany, supporting medical software manufacturers in overcoming regulatory hurdles and quality management. In 2019 I started as Head of Quality Management at a software company in Bochum, where I am also responsible for regulatory affairs and validation projects. Our offered solution is used in a GxP-regulated environment. There I advise the customers during the implementation. Know-How- Quality management systems according to ISO 13485 / ISO 9001 - Risk management according to ISO 14971 - Usability Engineering according to IEC 62366-1 - Software life cycle management according to IEC 62304 - Software validation according to GAMP 5 Softskills- Conduct one or two-day training sessions on one of the topics listed above - High communication skills (based on work as a consultant or in a leading role)
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