Annette Bitz
Clinical Research and Senior Biosafety Specialist
clinical research
Ambu A/S
Denmark
Biography
Annette Bitz Clinical Research and Senior Biosafety Specialist Ambu A/S Master's degree, Danmarks Tekniske Universitet Copenhagen Area, Capital Region, Denmark Responsibilities: * Participation in product development projects * Elaboration of Clinical evaluations * Elaboration of Biological Evaluations * Management of biocompatibility testing * Support of marketing and sales * Support of regulatory affairs, product registration and REACH * Project manager for implementation of RoHS2 * Member of the Global CSR team and responsible for CORP phthalatepolicy
Research Interest
Key competences: • >20 years of experience with development of Medical Devices including working in R&D, RA and Corporate Quality and Environmental Departments • 10 years of solid experience with Biological evaluations, toxicological assessments, preclinical testings and risk assessments in close collaboration with R&D and Clinical department • 7 years with project management activities within R&D or Clinical Department • 9 years of experience as Chairman for expert groups in Medicoindustrien and Danish Standard • Strong network in the Medical device industry