Regulatory Consultant – 510k Application – 0.4 FTE

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Copenhagen

We are working with a smaller Danish Medical Device company that are looking for support to register their product with the FDA. Now this would be on quite a strategic level as well, so you will really be a driving force behind this project being completed both in terms of the hands-on work but also advisory.

 

They expect that they will need support 2 days per week, ideally on-site in Copenhagen but we are happy to discuss flexibility here if it is needed. Ideally you are already based in the area or within commuting distance.

 

Naturally we would be interested to speak with those that have a few years of regulatory experience, specifically with registering new products in the US. This will be the main requirement for being considered in this position.

 

The start date is ASAP/end of summer and we estimate the contract to run between 6-12 months, at least for a start. So if this sounds like your type of role and you happen to have a few days of availability, we are happy to discuss this position as well as the hourly rates further.

 

You can simply apply via this page or by contacting Anders Sandberg at Black Swans Exist.

Contact

If you want to hear more about this opportunity and the company, or if you have any questions regarding the position, please do not hesitate to contact us. If you wish to apply for the position, please send an updated version of your CV, together with what questions you might have, and we will get in touch with you soon.