Quality Assurance and Regulatory Affairs
Senior Consultant and Principal Advisor Medical Device
Available for: Tasks
- In vitro diagnostics and medical device regulations.
- QMS management – ISO13485, 21 CFR part820.
- MDSAP regulations.
- Vigilance reporting and case handling.
- Post market surveillance.
- GMP and quality.
- Project management.
- People management.
- Change management.
- Process optimization – LEAN
Revised, optimized and implemented an entire global vigilance procedure in compliance with MDSAP requirements.
The new procedure ensured not only regulatory compliance but also a faster execution of vigilances cases.
Increased leadership satisfaction by 30% after 8 months employment as a QA manager.
Reduced the non-conformance lead time by 54% and the backlog by 75% within 2 months by implementing a behavioural change within the production and QA organization – no change was done to the process itself.
She is an experienced and passioned QA/RA consultant with seven years experience in safety, quality and regulation of in vitro diagnostics and medical devices, as well as knowledge and hands-on experience in in vitro diagnostic and medical device development and manufacturing.
She possesses a rare combination of a strong process and LEAN mindset and solid QA/RA knowledge which enables her to successfully translate regulatory requirements and legislations into practical and simple working instructions and procedures.
The key to her good results is her pragmatic approach and her ability to communicate and collaborate with a range of diverse stakeholder at all levels. As a person, she is very energetic and devoted to delivering solid results.
She is driven by challenges and an eager to always do better which shows in her work. Her background in management has provided her with a great business understanding and thereby the ability to customize processes and procedures to business needs.