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Yael Himmel-Shlomo

Yael Himmel-Shlomo

Director of Regulatory Affairs at RS Ness - Solutions For Life Science Companies

Israel

A QA/RA leader, experienced in leading quality and regulatory processes in a multi-disciplinary medical device company.
Key accomplishments:
- 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


Experience:

  • R&D Biochemist and Quality System Implementation (LeukoDx)
  • Quality and Regulatory Affairs Specialist (EarlySense)
  • Director of Regulatory Affairs (RS Ness - Solutions For Life Science Companies)
  • Quality and Regulatory Affairs Manager (EarlySense)
  • Strategic Business Consultant (Yael Himmel Strategic Consulting)
  • VP of Quality and Regulatory Affairs (LeukoDx)

Skills:

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