Regulatory Affairs Specialist

16-7-2018 zaventem
company profile

For a major player in the global pharmaceutical industry, we are looking for a Regulatory Affairs Specialist.

Interested? Email your resume and cover letter to

job description

Do the terms Regulatory Affairs and Quality Assurance mean anything to you? Do you have excellent researching skills Strong leadership talent?
We have the ideal job for you!

In this position, you will join the Philips Volcano International organization (part of the Business Group Image Guided Therapy).

As a RA Specialist your experience will be a real asset to the company and you'll find out there is still a lot to learn & discover.

- The set up and maintenance of all regulatory files will be your responsibility as well as the verification of the regulatory status in all countries of the EMEAI, LATAM & APAC
- You'll have the opportunity to set up a registration action plan, even for new products and you'll also be responsible for the follow-up
- Your documentation skills will become very useful when you'll be preparing and submitting product registration files
- Because you're well organised you'll be coordinating the documentation flow so requested licenses will be obtained
- As a team player with some good communication skills you'll be working together with different departments. You'll be assisting the Quality Department by updating SOP's, maintaining the vigilance system, carrying out CAPA's, ...

your contribution

If you can check off each of the following skills, you're the person I'm looking for!

- Diploma: Scientific degree (ex. biomedical, medical of similar degree)
- 3 years’ of experience in QA or RA in the area of Medical Devices
- Experience with Internal Audits
- Languages: English (written and spoken), knowledge of other languages is a plus
- Proficient in Microsoft Office: Word and Excel
- Strong leadership talent
- Good organization skills and multi-tasking abilities

what do we offer?

As an answer to your high performance & flexibility, Ausy offers you an interesting salary package, with some nice extra's like:
- Meal vouchers
- Hospitalization insurance
- Group insurance

And on top of this you'll become an even bigger expert in Regulatory Affairs!

project manager (m/f)
employment type
full time, freelance
contract type
long term contracts
your Randstad contact
Anaïs Bosmans 03 369 19 80
03 369 19 80