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Jan-Michael Krüger
Vice President Regulatory Affairs Gis Global @Olympus Corporation
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WORK HISTORY
Vice President Regulatory Affairs Gis Global @Olympus Corporation
Hamburg, DE
EDUCATION
Universität des Saarlandes
Diplom
SKILLS
ABOUT JAN-MICHAEL KRÜGER
Senior executive management, leadership expertise for large organizations, global program and project management expertise Management experience with global organisations Global Transformation Projects and Change Management Business Development and Post Merger Integration Expertise Certification and Quality Management ISO 9001, ISO 13485, CMDCAS, MDSAP, China GMP and FDA QSR Third Party Auditing, supplier auditing and internal auditing Global Regulatory Affairs Strategy and End to End process management Global Regulatory product registration expertise with focus experience in Europe, USA (510k and PMA), Middle East, Russian Federation, CIS Countries, EAEU, China, Japan, Brasil, Korea, Canada, Australia, New Zealand, ASEAN Region, Latin / South America and Africa Regulatory Compliance for Legal Manufacturers with focus on R&D, Manufacturing and Supply Chain Medical Device Regulation (EU-MDR), IVDR expertise MDD / AIMD expertise Risk Management according ISO 14971 AI, SaaMD, Deep Machine learning Regulatory expertise Clinical Studies, Monitoring ISO 14155 and Clinial Regulatory Affairs including Clincal Evaluation according MEDDEV and Chinese Regulation UDI, Eudamed Data, master data management expertise and PLM, RIMS expertise Quality Assurance in Research, Development, Manufacture and Distribution Validation and process control of manufacturing processes for Medical Device Cleanroom validation and maintenance experience Software lifecycle management ISO 62304 Electrical Safety, EMC, Cybersecurity and Usability of Medical Devices Global Post Market Surveillance and Complaint Management Expertise Global CAPA, Recall and FSCA management expertise and implementation Active Implantable Devices and High Risk Profile Medical Devices including Capital Equipment for Cardiology, Cardiac Surgery, Cardiac Rhythm Management, Atrial Fibrillation, Ophtamology, Neurosurgery, Neuromodulation and Orthopedics Active Medical Device for Ablation, Neuromodulation and Neurosurgery, Endoscopy, Urology, Gynecology, General Surgery, Orthopedics and Ear Nose Throat (ENT) Legal Affairs and third party claim management Representaton of the company and work in standardization and national / international manufacturer\'s association committees Government Affairs and Reimbursement Expertise Global market access strategies and product launch expertise
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