Support and implement product regulatory plans, provide guidance on global regulatory and product registrations for medical device,
- Preparation and registrations regulatory submissions and compile submissions
in USA, Canada and Europe. Or other required documents for Competent Authorities.
- Create and maintain Technical File/Documentation product file SW's requirements
- Follows up of mandatory requirements for registration: local certificates
- Communicates information and presents status updates on product/project activities to key internal/external when requested.
- Interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters.
- Practice on pFMEA, V&V IQPQOQ in production process
- Understanding the Quality medical device system (ISO 13485) and medical device regulations – is advantage
Bachelor’s degree or country equivalent in Engineering or Science or
related scientific discipline, or equivalent.
Key Attributes (Experience, skills and technical knowledge)
- Minimum of 2 years regulatory or equivalent experience within medical device company, or similar organization
- Excellent English written and Verbal communication skills.
- Proactive, high performance, result oriented and manage projects
- with ethical integrity
- Technical system skills (e.g. MS office applications, databases,
- efficient online research
- Manage multiple projects and deadlines
- The job involves traveling in Israel and abroad