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An accomplished, versatile, results-oriented clinical research professional with over 14 years of experience in the Pharmaceuticals & M...Ensuring compliance with the local regulatory, ICH-GCP, MEDDEV 2.7.1/Rev 4, EU MDR 2017/745, EU IVDR
I am passionate about the translation and application of research, turning science into products that have a positive outcome on people. My int...interdisciplinary projects, and communicated my findings to scientists, professionals and the general public
Regulatory notifications under IVDD - Czech republic, Slovakia Regulatory notifications under MDD - Central Eastern Europe Regulatory registrat...
Qualifications: MBiochem Molecular and Cellular Biochemistry, Oxford University PhD Haematopoetic Stem Cell Gene Therapy, University of Manches...affairs consultant specialising in clinical evaluations for the MDR and performance evaluations for the IVDRpost-market performance follow-up (PMPF) to the requirements of the In Vitro Diagnostics Regulation (IVDR
Experience in Lifesciences industry including over 18 years’ experience in QA, QMS, Regulatory, Manufacturing, Quality Unit (Commissioning, Qua...
20 years in Medical Devices, QA. RA, Validation for all Classifications of Medical Devices. MDR. IVDR expertise, with Software as a Medical Dev...IVDR expertise, with Software as a Medical Device, Usability Engineering and Risk Management.
Seasoned clinician innovator (MD, MBA) and data-driven strategist with unique healthcare and business acumen. Proficient in leading in-depth ma...
25+ years in medical device industry Expertise covering both active and non active medical device and IVD. Professional knowledge of ISO 13485,...
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