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Regulatory Affairs Coordinator

  • Location:

    Diegem, Belgium

  • Contact:

    Rebeca Martens

  • Job type:

    Contract

  • Contact phone:

    +32 15 28 40 47

  • Industry:

    Life Sciences

  • Contact email:

    rebeca.martens@oxfordcorp.com

Are you a junior who wants to jumpstart a career in regulatory affairs within the medical devices industry? Then this might be the opportunity for you!

Job Description

As Regulatory Affairs Coordinator you will assist and support the Regulatory Affairs Department in the execution of regulatory activities. You will contribute to the execution and of regulatory strategies concerning Medical Device Reporting.

Responsibilities

Under general supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate procedures and guidelines,you will have various responsibilities, e.g.:

  • Technical Dossier analysis of feedback provided to Notified Bodies and Questions received from Notified Bodies.
  • The Regulatory Affairs Coordinator assists and supports the team members in the execution of regulatory strategies impacting all CSS for MDR Implementation and Execution,
  • The Regulatory Affairs Coordinator gathers and assembles data necessary for the development of the regulatory aspects of project plans including tracking, planning and communication,
  • The Regulatory Affairs Coordinator assists in the execution of regulatory strategies for non-EU countries, including coordinating and tracking document requests,
  • The Regulatory Affairs Coordinator creates and approves ECO's pertaining to the Coordinator's projects and duties (including but not limited to SOPs, EU labeling approval),
  • The Regulatory Affairs Coordinator is responsible for administrative tasks to support the CSS MDR activities including preparation of meetings and general administrative activities,
  • The Regulatory Affairs Coordinator is responsible for compiling reports, presentations and creating flowcharts,
  • The Regulatory Affairs Coordinator researches, collects, cross-check data from different sources, and responds to requests from internal colleagues,
  • The Regulatory Affairs Coordinator is responsible for communicating business related issues or opportunities to next management level,
  • The Regulatory Affairs Coordinator is responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures,
  • The Regulatory Affairs Coordinator performs other duties assigned as needed


Requirements

  • You hold a university, bachelor's degree or equivalent
  • You have 0-2 years of work experience, preferably but not limited to regulatory affairs (Technical File/Design Dossier/Technical Dossier preparations or submissions)
  • You have a good command of database and spreadsheet software
  • You have excellent written and verbal communication skills in English
  • You have creative and advanced computer skills: Excel (mandatory), Power Point, One Note, Microsoft Team
  • You are an analytical, self-motivated, energetic, well organized, and self-disciplined person
  • You put attention to detail
  • You have the capacity to work autonomously
  • You have the ability to take on diverse tasks, good organizational skills
  • You have full proficiency in English
  • You have an existing right to work in Europe required


Benefits

  • You will receive a balanced salary package with fringe benefits (Hospital insurance, mobile phone, Group insurance, meal vouchers)
  • A nice work environment