Munich, Germany
Quality and Regulatory Affairs Consultant
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About Me
MBA and Biomedical Engineer with more than 7 years of experience in the Medical Device
Industry, highly interested in the structuration, implementation and maintenance of Quality
Management Systems according to the ISO[removed] & 2016 and 21 CFR part 820 and part 11.
Knowledgeable on different standards for:
• Risk Management
• Software lifecycle management Including Agile development
• Usability Engineering and human factors
• Medical Device Regulation and Directive
• Labeling Unique Device Identifier
Experienced with product classified as: Is, Im, IIa, IIb and III Europe
Recently started within the IVD industry for product class A and C Europe
Regulatory submissions in: USA, Canada and Europe
Support during regulatory submission in: All Latin America, Taiwan, China, Japan and Israel.
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