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RA Manager

Reports to: RA/QA manager

Location: HQ Mechelen, Belgium

Overview

The role holder is responsible for ensuring that Nipro Medical Europe (NME) meets all requirements of the current European Medical Devices Directive and Regulation and/or any other regulatory aspects connected to Nipro Medical Europe products and/or organization.

Responsibilities

  • Under the guidance and directions of the RAQA manager, to achieve agreed functional and personal objectives within area of responsibility.
  • Has end-responsibility over the Technical Files kept at NME and at NME factories (NRS and NPW)
  • Effectively manages, in line with procedures, all regulatory documentation connected with medical devices; records, document preparation, document approvals and document release.
  • Co-ordinates the detailed preparation and use of product specification in marketing material. Working closely with the marketing and sales team.
  • Supervise the PVNC/VNC process.
  • Monitors and communicates about changes in the Regulatory field affecting NME products.
  • Provide Regulatory support to NME customers, Mainly OEM customers.
  • Participates to teams working on improvements to the quality system and continuous improvement projects.
  • To produce and review SOPs relating to the Regulatory Affairs function.
  • Manages, guides and coaches the RA/QA assistant.
  • Demonstrates flexibility and mobility in order to optimize contact with the different business units and entities
  • The role holder will perform all tasks in accordance with JSOX and ISO quality requirements and taking Nipro values into account.

Education and Experience

  • Life Sciences related education is a plus.
  • Minimum of 3 years ‘experience, this experience should include a proven understanding of the regulatory process (Technical File) and experience in leading a project to a successful completion.
  • Knowledge of EU and Belgium registration.
  • Knowledge of ISO 13485 : 2016 is a plus.

Key skills

  • Excellent organization skills.
  • Ability to work well within a team.
  • Process orientated with good attention to detail.
  • Effective oral and written English communication skills.
  • Willingness to travel (Max 20%)

Interested?

Please send us your latest CV and motivational letter to:

Nipro Europe Group Companies
attn. Human Resources Department
Blokhuisstraat 42
2800 Mechelen
BELGIUM

or use the application form from the careers page


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