Regulatory specialist

Responsibilities

  • Prepare and maintain regulatory submissions, including 510(k), Technical Files, Letter-to-File and International Registration documentation
  • Define and execute regulatory strategy for new products and changes for existing products
  • Prepare, review and approve product development documents, including test protocols and reports, risk analysis documents, clinical validation protocols etc.
  • Participate in regulatory inspections and audits
Requirements

  • 4+ years in the medical device industry
  • Proven experience with preparing documentation for regulatory submissions (510(k), CE technical files)
  • Knowledge of statistical techniques in clinical validation studies
  • Experience with software medical device regulation – an advantage
  • Ability to perform well in a fast paced startup environment
  • Self driven, communicative, and fun to work with!
Desirable skills/qualifications

  • Excellent written and verbal communication skills: Hebrew and English