Quality & Validation is an ambitious, growing and successful domain within the Life Sciences department of Altran Netherlands. This domain is responsible for projects at clients in the Life Sciences (Biotech, Pharmaceuticals and Medical Devices) and Food & Beverage industry.
In addition to our team we are looking for a Regulatory Affairs Specialist with 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, variations & renewals, regulatory information management.
As a Regulatory Affairs Specialist you are a project member and operational support to adapt to evolving regulatory constraints. Your business process expertise: all pharmaceutical forms, clinical trials, medical devices in a Life Sciences environment.
What you will be doing
- Work on Technical documentation (Regulatory).
- Be involved in safety and regulatory compliance.
- You envision the different Life Sciences sectors combined with expertise of local regulatory environments at international level.
- Perform by a unique end-to-end approach combining technology, usage and verification & validation.
- 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
- Familiar with relevant regulations and standards (eg. EU MDD, FDA, WHO, ISO 13485)
- Strong verbal and writing skills in English, Dutch is a pré
Who are you?
- You are a team player, 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 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
- an open-ended contract, a salary in accordance with market conditions and a lease car
- an individual and a collective bonus
- extensive training and educational opportunities
- the opportunity to share your experiences, know-how and expertise with other enthusiastic IT specialists in related disciplines at various types of get-togethers such as knowledge sessions, tailor-made courses, workshops and gatherings of the Java Technology Group.
- an innovation budget and access to our state-of-the-art Innovation LAB
Bedrijfsprofiel Altran Netherlands
Altran is all about innovation. We provide innovative answers to the big challenges of today and the teams in our Technical Applications unit are instrumental in developing the products and services of tomorrow. Furthermore, our employees have broad interests and are highly proficient when it comes to programming languages, operating systems and development methods and technologies.
By clicking the application button, you will be navigated to the website of Altran. In case the link is not working anymore, the vacancy has expired and you will no longer be able to apply. We try to keep our job database as up-to-date as possible, we would very much appreciate it if you could let us know in case a link is not working.
Would you like to be kept up-to-date about other interesting jobs in Twente, then sign up here and create your own job account!
7554 RR HENGELO