Consultant Regulatory Affairs

  • Management Consulting
  • Medior
  • Eindhoven

Do you believe that technology can make a big impact on business and society? Are you driven by getting the best out of yourself and your team? Do you know like no other what Regulatory Affairs should look like? Then join our team of innovation makers in the Netherlands as a Consultant Regulatory Affairs.

Life Sciences is an ambitious, growing and successful domain within the Quality & Validation department of Altran NL. This unit is responsible for clients in Food & Beverage, Chemicals and the Life Sciences (Biotech, Pharmaceuticals and Medical Devices) sectors. Our motivation is to successfully help our clients with solutions to their problems.

We are looking for an innovation maker with in-depth knowledge of Regulatory Affairs and also a broad knowledge of Submission and follow-up of evaluation procedures with health authorities, Coordination and preparation of the Marketing Authorization Application file, CE marking, Promotional material management, Life cycle management, CC, Variations & renewals, Regulatory information management.
Project management and operational support to adapt to evolving regulatory constraints and ensure that compliance requirements are respected and maintained without impacting operations.
Business process expertise: all pharmaceutical forms, clinical trials, medical devices in a Life Sciences environment. You will be involved in the most exciting projects in which you will expand your expertise by working closely with our clients to really make innovation matter.

As a consultant you?

  • Provide system assessment, establish roadmaps and give advice on technology choice
  • Perform by a unique end-to-end approach combining technology, usage and verification & validation
  • Be involved in safety, regulatory compliance and data (cyber)security issues
  • Work on Technical documentation (Regulatory)
  • You envision the different Life Sciences sectors combined with expertise of local regulatory environments at international level.
  • Perform permanent regulatory watch and capitalisation of best practices and cross sectorial benchmarks.

What do you bring?

  • Bachelor or University degree in (Bio)Medical Engineering, Regulatory, or equivalent
  • Experienced in regulatory affairs and project management
  • Perform by a unique end-to-end approach combining technology, usage and verification & validation
  • Be involved in safety, regulatory compliance and data (cyber)security issues
  • Familiar with relevant regulations and standards (eg. EU MDD, FDA, ISO 13485, IEC 62302)
  • Good knowledge of Big Data and Analytics is an absolute plus
  • Strong verbal and writing skills in Dutch and English

Who are you?

  • You are a team player, enthusiastic, client and goal oriented, ambitious and ready to take on a challenge
  • You can adapt easily in new environments and have developed organizational sensitivity
  • You have a creative mind and like to develop yourself more in skills and knowledge by training and coaching and working on innovative, technically challenging and complex projects
  • You can see the bigger picture, have a strong analytical mind and approach challenges from a practical standpoint
  • You are flexible and can communicate on different levels

What do we offer?

  • A permanent contract with a competitive salary
  • Profit sharing and a variable bonus plan
  • A lease car
  • Extensive internal training programs

As global leader in innovation and high-tech engineering consulting, we work side by side with our clients in the creation and development of new products and services. We are on the cutting edge of technology and have established ourselves as the go-to partner for technical innovation and process improvement. Altran is proud to be the leader in its field.

Solliciteer nu!

Ben jij klaar om je toekomst bij Altran te verkennen? We nodigen je graag uit om kennis te komen maken en je onze wereld te laten zien. Solliciteer nu en vertel ons jouw ambities!

Solliciteren

Zijn er nog onduidelijkheden of heb je vragen? Neem contact op met:

Jeffrey Leunnissen