Regulatory Affairs / QA for Start-up - DK

This opportunity is essentially a chance to get into a well funded start-up with a promising product, the product have the possibility to change the lives for a lot of people in third world countries. Therefor it is very important that the candidate has passion and can draw on a broad knowledge from Regulatory Affairs, Medical Devices and IVDs so this product becomes a massive success.
What the candidate would be doing in this position is essentially setting the direction of the quality and regulatory strategy for the products. Whit this responsibility follows a lot of autonomy and freedom to do the job the way you find best. The right candidate would experience that the results of your hard work is directly pointing towards you, so the right candidate has confidence and like the challenge it would be creating a success story from the bottom up.

The right candidate for this position:

• Is highly motivated and can work alone but also as part of a team. You have already some years of experience in regulatory affairs related to IVD and you enjoy working in a start-up environment.
• Has 3-4 years experience in a regulated industry (e.g. medical devices, IVD)
• Experience in regulatory approval of IVD products
• Knowledge of ISO 13485
• Knowledge of FDA, regulatory requirements in South East Asia or South America is a plus
• Fluency in English, both verbally and in writing

If this opportunity sounds like something for you, then please forward your CV in a word format to my E-mail: P.Christensen@nonstop-recruitment.com, or contact me, Per, on +46 846 505 819.
If this does not sound like the opportunity you where looking for but you might be interested in other positions, then please feel free to contact me for a noncommitting conversation about your opportunities.