Regulatory Affairs Manager

About Us: We are currently seeking a dedicated Person who managed Regulatory Affairs and ensures the appropriate licensing, marketing and legal compliance of medical devices. The role function is a link between company and regulatory authority, ensuring that products are marketed and distributed in compliance with appropriate legislation. He / She guarantees shared understanding and alignment on all dossiers or projects. Key Responsibilities:

• Proper follow ups & Visiting DRAP office.
• Prepare and submit notification/registration/authorization dossiers:
• Coordination and follow-up of local regulatory submissions.
• Contact and exchange with regulatory authorities and notified bodies.
• Ensure that the portfolio of products are distributed in compliance with the approved authorization, regulatory guidelines and legislation.
• Initiate action when needed by preparing (technical and scientifically writing) and coordinating the appropriate regulatory dossiers to inform the authorities on changes or other requirements.
• Reports regularly on the status of the products or projects and provide response to questions of internal (management, other departments) and external customers (vendors, regulatory authorities) on behalf of Company.
• Inform proactively and timely internal and external customers on the status of regulatory dossiers or on any regulatory/scientific change which might have impact on the compliance of the portfolio to the applicable legislation.
• Proactive follow up and monitoring of the current legal and regulatory requirements concerning registration of medical devices and initiate implementation of relevant changes.
• Weekly reports and discussions on DRAP registration of products.
• Ensure compliance with regulatory requirements governing the distribution and use of medical equipment including licenses, certification, and reporting obligations.