Regulatory Affairs Specialist, MDR Biotech, Amersfoort
Do you want to work for a Global leader in bio tech medical devices?
This is an amazing opportunity for a Regulatory Affairs specialist with ambitions to work for a growing international manufacturer of orthobiologics.
In this role you will deal with EU and US registrations.
Not only are you going to work with very interesting products; they are also expanding their product portfolio.
Which will give you the chance to work closely with R&D and the development of highly innovative products.
Furthermore the company values a good work-life balance so working 32 is possible.
The cherry on top; you will work within a supportive team.
Your responsibilities would be:
- New registrations and variations of medical devices within the EU and global level
- Responsible for complaint handling
- Risk assesments and reporting
- handling recalls
- Filing of documents
- You have a masters degree in a life science discipline
- Minimum of 3 years of experience in the registrations of medical devices
- Knowledge about the latest MDR registrations for the EU and US CFR21
- You speak fluent English, Dutch or any other language is a big plus but not necessary
What you can expect:
- Work for a stable, growing organisation with global expanding activities.
- The company values their employees and a good work-life balance.
- You will work in a supportive team that does a lot team building activities together.
- Your perhaps awkward sense of humour will be appreciated as your colleagues would like to support you in any case and still laugh at your jokes.
- Warm and welcoming on boarding with a lot of flexibility.
Sent me your number and I will contact you within 24 hours to give you more details. If you know of someone that could be interested share their number and I will contact them; help the people in your network this way.
Debie van den Dries
Consultant / Headhunter Pharma Regulatory Affairs Netherlands
Switzerland Tel: +41 43 508 0817 | Int Ext: 3394
Netherlands Tel: +31 207 091 070
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