תיאור המשרה | Provide regulatory support for product-specific activities related to gaining and maintaining market approval in Europe, United States, and other countries worldwide, including compiling data, organizing and preparing regulatory documents.
Work in subject to QA/RA Manager.
Key Job Functions:
- Manage the preparation of regulatory submissions for assigned products consistent with regulatory policies and regulations such as FDA, EU, and License Applications in other foreign countries, Maintenance of the European Design Dossiers, license renewals, Notifications to Competent Authorities in Europe, 510K, License Applications or any additional applicable submissions for pre- and post-marketed products.
- Managing the implementation of the new EU MDR regulation. Knowledge and experience with ISO-13485 requirements.
- Serves as RA representative on product development teams: Identification of regulatory requirements during the design and development stage and after post marketing approval. Participates and represents RA in design control and risk management processes, ECO.
- Review documents and labeling for compliance with regulatory requirements.
- Interpretation of regulatory policies, procedures, and regulations on how they change and/or impact product approvals and submissions.
- Managing processes relating to regulatory requirements as clinical evaluation, post market surveillance, managing risk analysis process.
Experience requirements:
- Experience of working in medical device within the regulatory environment (2-3 years’ experience).
- Experience with at least Class I sterile and / or Class-II devices.
- Experience with maintenance of Technical Files, Canadian Medical Device Submissions or equivalent regulatory files.
- Written skills to prepare documents including but not limited to strategy documents.
- Knowledge and experience with ISO 14971, MED DEV 2.7.1 – an advantage.
- Experience with FDA inspection – an advantage.
- Acknowledged regulatory course graduate.
Required skills:
- Able to work independently with excellent time management skills
- Excellent organizational, problem solving, program development, computer (Microsoft Office applications) skills and team building skills.
- English: High level, oral and written.
- Self-learning capabilities.
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