סקירה כללית
The QA/RA Project Manager is responsible for Regulatory Affairs & Quality Assurance. Job Description:
• Lead compiling and preparing materials for submission to regulatory authorities. Lead Quality Management System (QMS) and medical device development and production, according to the project’s scope and needs.
• Coordinate and document internal processes, such as employees training and qualifications, internal audits, Corrective and Preventive Actions (CAPAs) and Management Reviews.
• Lead and/or support the R&D Team in design control activities and related processes such as Design History File (DHF) maintenance, Verification and Validation (V&V) testing, risk management and change control.
• Evaluate, approve, and monitor the customer’s suppliers / clients and sub-contractors. Required Background:
• Previous experience in the QA and/or RA fields in the medical device industry including SW.
• Relevant University/Professional background (life science, biomedical, biochemistry, etc.) Required Skills:
• Passionate about life sciences, technology, and innovation.
• Strong communication and interpersonal skills.
• Highly motivated, committed, and responsible.
• Ability to work independently, and as part of a team.
• Willing to learn.
• Good verbal and written English skills.
דרישות המשרה
, internal audits, Corrective and Preventive Actions (CAPAs) and Management Reviews.
• Lead and/or support the R&D Team in design control activities and related processes such as Design History File (DHF) maintenance, Verification and Validation (V&V) testing, risk management and change control.
• Evaluate, approve, and monitor the customer’s suppliers / clients and sub-contractors. Required Backg
