We are recruiting for a Senior Regulatory Affairs role with a well-established company based in the Minneapolis area. The position will be remote so you will be able to work from home anywhere in the US. Ideal candidate will have 7+ years’ experience in medical device Regulatory Affairs and have been the sole author of a 510(k) submission. Looking for someone well versed in regulatory strategy, design/change control experience, understanding risk tolerance and FDA interaction. Software experience is a major plus. This opportunity will also afford the exposure to a variety of devices/indications.
