Personal Information
Organization / Workplace
Zürich Area, Switzerland Switzerland
Occupation
Regulatory Affairs Manager at Roche Diagnostics
About
Highly motivated, dynamic and experienced Regulatory Affairs Manager with excellent communication skills. Experienced in many different areas of Medical Device (including implants) and IVD technology and deep knowledge of aspects such as project management, product development & launch processes, change management, risk management, SW development and Usability.
High personal and professional integrity, able to relate to and create trust in people. Dependable and reliable in supporting team effort, confident and persuasive, able to motivate and communicate.
Strong negotiations skills, ability to manage by influencing, convincing and conducting meetings at all levels.
- Presentations
- Documents
- Infographics
Use of left over samples under the IVDR and GDPR
Erik Vollebregt
•
6 years ago
Regulation of Economic Operators under the MDR and IVDR
Erik Vollebregt
•
6 years ago
Kazakhstan: What information is mandatory on medical device label?
Alexey Stepanov
•
9 years ago
Medical Device Labeling in Russia
Alexey Stepanov
•
8 years ago
FDA Expectations for Traceability in Device & Diagnostic Design
Seapine Software
•
12 years ago
Trends in EU regulation of software as medical device
Erik Vollebregt
•
6 years ago
Becoming more efficient
Dalibor Sever
•
8 years ago
mHealth Israel_Digital Health_The Regulatory Landscape 2017
Levi Shapiro
•
7 years ago
EU cybersecurity requirements under current and future medical devices regulation
Erik Vollebregt
•
7 years ago
New EU Legislation on Medical Devices By G. Bos - BSI (Qserve Conference 2013)
qserveconference2013
•
10 years ago
Travel Tips Learned from Japan! - #japan #traveltips
Empowered Presentations
•
12 years ago