RA Referent

About the Position:

At Alpha-Bio Tec. we're passionate about creating innovative dental devices that improve patient lives! As a RA referent in our Regulation Affairs & Quality Assurance department, you'll be responsible for making sure our products are regulatory approved in dozens of countries worldwide! This role is ideal for someone who enjoys a fast-paced environment, has a strong understanding of regulations, and thrives on clear communication, order, and organization. 

What responsibilities will you have?

Prototype development:

  • Periodic submissions, one-time submissions, new products submissions, and maintenance of existing certificates to Israeli MOH (AMAR), LATAM authorities etc.
  • Prepare samples for submission purpose
  • Communicate with internal and external interfaces: competent authorities in Israel, relevant RA persons in OpCos, distributors, health care professionals and health authorities according to a work plan
  • Prepare and update ECOs of labeling: labels, IFUs & translations
  • Issue purchase orders & regulatory status updates on the Priority systems
  • Support RA projects following business needs in Israel and LATAM countries

You will be a perfect fit for this role if you meet the following requirements:

  • Bachelor's degree in a Sciences / Life sciences or other relevant field 
  • Minimum of one year of experience as a regulatory affairs or registration assistant at a medical devices company
  • High level English (Fluent of proficient) in reading, writing, speaking and understanding technical documents
  • Excellent organizational skills for accurate documentation 
  • Technical skills and basic engineering knowledge necessary for RA practices: reviewing product drawings, specifications etc. and preparing technical specifications documents 
  • Excellent communication skills for cross-company interfaces & interactions (e.g.: QA, R&D Product Management, Marketing etc.) 
  • Organizational & coordinating skills for leading small projects, including risk management & resource planning
  • High self-motivation for independent working