תיאור התפקיד
.Handling the Regulatory Affairs and Quality Assurance in the organization
Roles and Responsibilities
•Prepare QA procedures
•Prepare Post Marketing reports
•Manage Design Validation & Verification, and Design History Files
•Follow regulatory pathways and regulatory plans
•GAP Analys is for new standards/guidance documents
•Prepare annual management reviews
•Liaise with regulatory bodies (FDA, NB etc.)
•Preparation of regulatory files (EU Technical Files, FDA submissions etc.)
.Ensure documents are in compliance with current regulations and regulatory guidance
•Familiar with Quality Management Systems including: 21 CFR 820, ISO 13485 (2016), MDD & CE marking, MDSAP
•Manage the quality related activities. (ECO, MRB, CAPA, training and qualifications. Internal and external Audits)
•Provide regulatory strategic direction on projects/products
דרישות התפקיד
•Oral and writing communication skills in English
•Education: Bachelors in sciences (or higher) or engineering
•2 years: experience in RA&QA
Surgical robotics system
Full-time or part-time (flex commuting hours)
Jerusalem, Har Hotzvim
