Regulatory Affairs Specialist

תיאור התפקיד

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

דרישות התפקיד

Education

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

שליחת קורות חיים למשרה זו

File name:

File size: