Regulatory Officer

☞ Barco

Ver: 130

Dia de atualização: 26-11-2025

Localização: Kortrijk West Flanders

Categoria: Marketing / PR

Indústria:

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Conteúdo do emprego

Date:Aug 25, 2023

Location: Kortrijk, BE

Company:Barco

Main accountabilities
As a Regulatory Officer, you will be supporting the Regulatory team with general activities and play an active role in the implementation of the IVDR requirements within the Healthcare Business unit and prepare for submission of new developed devices to the Notified body.


IVDR project:
  • Understand, evaluate and implement relevant regulations, related standards and guidances
  • Guide the R&D, Quality, Regulatory and Commercial teams in updating the relevant processes
  • Ensure stakeholders are trained in line with expectations of the IVD(R)
  • Support the developments of the technical and performance documentation and review before NB submission

General Regulatory work:

  • Premarket activities
  • Provides regulatory input and technical guidance on global regulatory requirements to product development teams
  • Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission (eg 510k, NB approval process …)
  • Review and approve labelling and marketing materials info (like brochures, marketing material, product and package labels, …)
  • Evaluate regulatory aspects of design changes and reviewapprove Change Impact Assessments
  • Worldwide product registrations
  • Ensure registration of medical device products in their requested countries in accordance with the local legislations
  • Review UDI implementation and ensure UDI information is uploaded to country databases
  • Regulatory Intelligence
  • Evaluate regulatory changes and initiate (& follow up) change projects based on changes in medical device regulations or in applicable standards
  • Ensure technical documentation remains up to date as required by regulators in relevant regions and for relevant products.

Required competencies

  • Profound knowledge of the medical device regulations such as IVDR, MDR, FDA, ...
  • Able to comprehend and apply regulatory requirements and translate towards the different teams
  • Demonstrate ethical behavior by ensuring integrity in personal and organizational practices; respects people and principles, including professional, ethical and human values; coaches and serves as a role model for others.
  • Excellent verbal and written communication skills, listening skills
  • Ability to deal with and manage a diverse and demanding workload
  • Ability to work in teams

Let’s "wow" you with
  • A variety of inhouse trainings at our Barco University so you can continuously grow & learn as a professional.
  • A healthy working environment with interesting workshops, sport activities, diverse & fresh lunch/snack breaks - with our own coffee bar and restaurant in Kortrijk - and many more options as we care about your wellbeing.
  • The opportunity to work for an international market leader where innovation matters.
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Data limite: 10-01-2026

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