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Isabella Bauer is an experienced quality and regulatory affairs professional currently serving as the Quality & Regulatory Affairs Manager at Akina since January 2023. Responsibilities include managing quality and regulatory topics for medical device software, leading MDR conformity assessments, and implementing ISO 13485 quality management systems. Prior experience includes a consultancy role at PwC, focusing on R&D and quality optimization for pharmaceutical and MedTech sectors, and a quality engineering position at Smith & Nephew, where Isabella specialized in EU-MDR compliance. Additional roles include a master thesis at Stryker on osteosynthesis implants and internships at DePuy Synthes Companies and ETH Zürich. Educational qualifications comprise a Master of Science in Medical Technology and a Bachelor of Science in Health Sciences & Technology from ETH Zürich, along with a current Certificate of Advanced Studies in Data Privacy Officer from Lucerne University of Applied Sciences and Arts.