Hossein Nadjafizadeh
R & d and Pmo Leadership Consultant @Unitech Consulting
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WORK HISTORY
R & d and Pmo Leadership Consultant @Unitech Consulting
Nancy, FR
Consultant activities : R&D and PMO Leadership for Industrial and medical device companies including design and manufacturing, innovation, industrialization, GMP, FDA regulations, international product registration requirements and intellectual property strategies.
EDUCATION
ENSEM-Ecole Nationale Supérieure d'Electricité et de Mécanique
Diplôme d’ingénieur, Electrical Engineer
SKILLS
ABOUT HOSSEIN NADJAFIZADEH
A highly qualified and experienced Senior Technical and Regulatory Manager, with an extensive background in the medical devices industry. Demonstrates considerable technical expertise combined with an innovative approach based on industry best practice. Has successfully developed and launched numerous new products and acquired a comprehensive understanding of ISO standards (13485, 14971 and 10993), EU MDR, CE Mark certification and FDA regulations. Has extensive knowledge of requirements for international product registration. A strong knowledge of working with multi-site, multi-disciplinary teams to achieve excellent results. Has proactively contributed and led intellectual property activities. Expertise: • Technical and regulatory management • Management of international and multidisciplinary engineering project teams • Medical devices new product development expertise • Long-term intellectual property strategies • Patent portfolios management • Expertise in ISO standards • FDA design control requirements • Medical devices registration • Six Sigma & LEAN • Disruptive Innovation theory & practice
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