«You can't tie a knot with just one hand.»

Education and Training

• University degree in medicine (MD)

• CAS “Clinical Trial Management” (USZ)

• CAS “Pharmaceuticals - From Research to Market” (ETH Zurich)

•  Various further educations for example “Quality System Manager”, “ISO 13485”, “Technical Documentation for Medical Devices”, “Clinical Evaluation”, “Good practices in blood components and medicinal products referring to GPG and GMP” and “Process and Components Controls in a Blood Transfusion Establishment”

 

Work Experience

Suzana Bosanac has been working in the pharmaceutical and medical device industry since 1994. Since 2014 she has been working in quality management as lead auditor and product manager for a certification body in the areas of health care and medical devices.

Additionally, since 2017 she has been working in the field of blood products and labile materials as a medical expert and contact person in quality management. She also works in her own company BES GmbH as an independent QM consultant/ auditor for medical devices and in the health care sector.

She has gained experience in regulatory affairs, medical, product management, sales and marketing in international companies (Fresenius, Becton Dickinson, Pfizer).

 

Specific Expertise and Experiences

• Auditing and Consulting in Healthcare (ISO 9001)

• Auditing and Consulting for Medical Devices Industry (ISO 13485, ISO 9001)

• Regulatory Affairs of Medical Devices (MDR)

• Monitoring and reporting regarding Swiss and international regulations, laws, standards and rules

• Compliance with post market surveillance and vigilance requirements

• Complaint Management

• Clinical Evaluation and Clinical Trial Management (ICH)

• Communication with Notify Bodies, Competent Authorities and Opinion Leaders

• Presentations and Workshops