לצערנו המשרה כבר לא בתוקף

Regulatory manager

5-6 שנים |
משרה מלאה
| 19/09/2021
תיאור משרה

This position reports to VP Clinical Research and Regulation

Responsibilities:
· Coordination of regulatory activities
· Writing and presenting regulatory plans
· Generates, edit and review regulatory documents for submission to the health authorities
· Support the clinical sites on implementation of the ethical and regulatory requirement for the conduct of the clinical trial
· Responsibility for the Medical Device Reporting and Adverse Event Reporting to the authorities
· Clinical data analysis
· Generate clinical evaluation reports

דרישות התפקיד

· At least master degree in Life Science
· Comprehensive knowledge and experience with the (EU) 2017 / 745 regulation and their MDCG guidelines, and / or 510(k), PMA regulation / guidelines in the US
· Previous experience with writing of Clinical Evaluation Reports and / or Regulatory Pathways Reviews
• Previous experience in compiling Technical File
• Previous experience in CE mark applications / FDA clearance processes
• Previous experience in class III medical device
· High technical writing capabilities in English