job description:
• Responsibility for all company activities in the field of clinical trials and regulatory submissions.
• Responsibility for the design, implementation and maintenance of an efficient quality system.
• Responsibility for establishing a regulatory strategy and directing the product design to the standard requirements, including risk management.
• Responsible for planning, building and accompanying clinical trials, including submission to ethics committees in Israel and abroad.
• Writing and managing submission documents to the regulatory authorities for medical devices.
• Report the quality system performance to the relevant authorities and company management as required.
Requirements:
• 10 + years of experience
• International regulatory experience in device companies.
• Experience working with the US FDA, EU, accredited organizations and / or international regulators
• Experience in successful preparation, submission and approval of a product in track 510 (k)
• Experience in preparing and accompanying a clinical trial
• Scientific degree
• Excellent analytical skills
• Full proficiency of working in English
• Experience in writing reports and business correspondence
• Proficiency in Microsoft Office including Excel, PowerPoint and MS Project
