Sandra Soniec meditec Consulting GmbH Obermoosstrasse 23 3067 Boll, Schweiz phone: +41 31 535 31 93 mobile: +41 79 727 60 49 email: soniec @meditec-consulting.ch web: www.meditec-consulting.ch Profile Topics Regulatory Affairs: Medical Devices, IVDs, Combination Products Quality Management: ISO 13485, 21 CFR Part 820 (FDA QSR) Auditing and FDA Inspections Project Management Training

Education

• Biomedical Engineer, University of Applied Sciences Lübeck, Germany

Professional Career

• since 02/2004: meditec Consulting GmbH, Managing Director
• 01/1999 – 12/2003: Disetronic Medical Systems AG, Burgdorf, Regulatory Specialist / Manager Regulatory Affairs

Languages

• German native speaker
• Englisch business fluent
• Basic knowledge French and Spanish