RA Specialist
RA Specialist
06/09/2022
As RA Specialist, you will take part in new product submissions for regulatory approval in US, Europe, Japan, China, Brazil, Australia and more
Scope & Responsibilities:
• Preparing, coordinating, tracking, and following up on approvals for medical device submissions
• Preparation and management of EU MDR technical documentation submissions • Oversees of CER, PMS and PMCF activities, including customer complaints, vigilance, and recall
• Participate in regulatory inspections and audits.
• Prepare regulatory assessments for design changes
• Developing labelling according to applicable regulatory requirements
Requirements:
• B.Sc. or above in Engineering or Life Sciences
• Excellent English – experience in writing regulatory and clinical documents
• 1-2 years experience in RA of medical device (preferred)
• Experience in the Neurovascular field, an advantage
• Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents
• Eye for detail and accuracy
• Experience working on multiple projects with aggressive timelines
משרה זו סגורה ולא ניתן לשלוח אליה קורות חיים.