Pharmatechnical Regulatory Manager - Devices and Combination Products
Health & Nutrition
Senior Life Science professional with strong background in Regulatory Affairs, Quality Assurance, Medical Devices and Regenerative Medicine (Advanced Therapy Medicinal Products). Medical Doctor with significant expertise in Immunology, Immunotoxicology, In vitro Toxicology and Inflammatory Diseases/ Oncology.
More than 20 years of international experience in quality assurance and regulatory affairs including cell therapeutics and medical devices. More than 15 years of experience in Applied Research and Contract research. More than 10 year hands-on experience and profound entrepreneurial background in business development of biotech/medtech start-ups. Direct leadership experience in international internal and external teams. Possess recognized experience in medical device development, materials, cell therapeutics, cell- based systems and approval of clinical trials including first in man studies. Ability to integrate strategic and global big picture thinking with operational and project management skills.