- Managing and implementing regulatory strategy for different projects.
- Prepare and coordinate regulatory submissions for medical device %28e.g., ISO, FDA, CE, safety reports, 510 %28k%29, Technical files, Amar approvals, etc.%29 in accordance with applicable regulations.
- Assisting various departments in the organization, such as R&D and Marketing, from regulatory aspects. Starting from product definition to release.
- Make sure that all products international registration files are maintain as necessary to obtain and sustain product approval.
- Communicate with international regulatory agencies regarding registrations and renewal submissions.
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
- Review of ECOs to provide regulatory assessment.REQUIREMENTS
- BA / MA Graduate %28in science fields%29.
· 1-2 regulatory years of experience in Medical Devices
· Experience in preparing and coordinating FDA and CE submissions
· Regulatory Knowledge of relevant standards for electrical medical equipment
· Regulatory experience in medical equipment companies and familiarity with FDA requirements, the requirements of European Directive and Canadian requirements
· Responsible, self-motivated, organized and meticulous.
· Able to multitask and meet the targets set.
· Fluent in English, Excellent expression skills – written and verbal.
