QA/RA Consultant at HaMaDa Regulatory, Clinical & Quality Affairs @ Israel
Director of Regulatory Affairs at RS Ness - Solutions For Life Science Companies
A QA/RA leader, experienced in leading quality and regulatory processes in a multi-disciplinary medical device company.
- Established a Quality Management System in an IVD company, and led the implementation throughout the company, to the successful ISO 13485 certification by a leading certification body
- Managed EU technical files, Essential Requirements, and Hazards analysis per ISO 14971
- Designed analytical testing plans for design V&V and for an FDA 510(k) pre-submission; analyzing industry standards and scientific literature