03. 07. 2019

Regulatory Affairs Assistant

RegijaBeogradski region

Vrsta posla:Stručne i rukovodeće pozicije


Opis
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Our client is Medtronic, a global leader in medical technology, services, and solutions. Medtronic pushes the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. In order to support their growing business in Serbian market, Adecco is looking for motivated candidates for a temporary engagement.

Main purpose of job
The Regulatory Affairs Assistant provides support to the regulatory team and maintains key information in various systems in accordance with local legislation and Medtronic SOPs. Ensures timely approved medical devices by local CA in Serbia, Montenegro and Macedonia. 

Required qualifications:
  • Bachelor degree or final year of Pharmacy, Medicine or Dentistry
  • High level of understanding of medical terminology
  • Fluency in English 
  • PC literacy (MS Office)

Main responsibilities:  
  • Assists the team in preparation of dossier for all registration activities
  • Collects, distributes and tracks receipt of regulatory documents and other related documents through the life cycle of medical device’s registration process
  • Maintains trackers for essential regulatory related documents as needed
  • Ensure compliance with the application and communication of all Medtronic policies and procedures
  • Provides administrative support to regulatory team as needed for regulatory related tasks
  • Ensures that regulatory documents are uploaded accurately and within expected timelines
  • Accountable for any mass mailings or communications required to support regulatory team
  • Responsible for ensuring that the mandatory regulatory entries are made in the appropriate systems
  • Understands regulatory specific manuals/plans to ensure quality and that deliverables are met across markets
  • Upon notification from regulatory team, updates mandatory dates into PPM, BOX, Insight

Candidate’s profile:
  • Effective verbal and written communication skills at all levels
  • Strong attention to details, planning and organizational skills
  • Ability to handle multiple priorities and demands in fast-paced environment
  • Highly motivated, self-starter, able to work independently 
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Broj oglasa JN -072019-23694