RA IVD - CE marking - Training on the job

I am looking for a candidate, that want to join a well funded start-up with products that really can make a difference to millions of people, that is why FDA has put a lot of funding into the device. Would you help me make this happen? If you have around 2 years working in IVD devices and you have Experience in CE marking of IVD devices, this is the perfect role for you.

The company is still young, and with only 13 people in the company you will be the only candidate in Regulatory Affairs and you will be responsible for driving the department towards success, if this scares you a bit, you are probably the right candidate, because, it is a very important position for the company. There are consultants attached to the company at the moment to fill the position, so the process of integrating you to the company will be a gliding transition with training on the job from some of the best in the field, to ensure that your personal development, of becoming the Regulatory Manager, is successful.

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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 2-3 years experience in a regulated industry (e.g. medical devices, IVD)
• Experience in CE marking of IVD
• 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.