sitem-insel AG

Sandra Soniec



Modules

Translational Medicine and Biomedical Entrepreneurship:

Medical Device Regulatory Affairs and Quality Assurance:


Biography

Sandra Soniec holds a degree in Biomedical engineering and has 20+ experience in the healthcare and life sciences regulatory environment, providing technical and expert support to start-ups and global players. In 2004, Sandra founded meditec Consulting, a consulting firm providing regulatory affairs and quality affairs services and solutions with focus on medical devices, in vitro diagnostics and combination products.

Sandra began her career in 1999 as Regulatory Affairs Specialist at Disetronic Medical Systems, where she built up the regulatory affairs team. In her current role, Sandra supports teams developing RA Strategies for accessing new markets, understanding complex regulatory and quality requirements and managing audits, inspections and changes in regulations.