Job Description

Regulatory Affairs Specialist, RA Specialist, FDA, 510(K), SaMD, Remote, COR5716

The Role

This is an excellent Regulatory Affairs Specialist / RA Specialist, working for a company with a growing reputation in their field. The successful Regulatory Affairs Specialist / RA Specialist will have hands-on knowledge of FDA regulations, ISO standards & SaMD – as well as proven experience working with medical devices that use AI & Machine Learning. The purpose of this role is to provide expert advice and guidance on FDA approvals and 510(k) submissions.

The Company

The Regulatory Affairs Specialist / RA Specialist will join an innovative Machine Learning MedTech start-up based-in Cambridge. The Regulatory Affairs Specialist / RA Specialist will contribute to a supportive team environment, which rewards hard work and innovative thinking. The current work pattern in place is fully remote.

Benefits

Some of the benefits on offer for the Regulatory Affairs Specialist / RA Specialist, include:

Flexible / Remote working – With options to go into the office if you want to!  25 days holiday + BH Employee share options 

What’s Required?

The Ideal candidate for the role will have some of the following:

Proven experience and knowledge of FDA regulations and requirements for approvals  Prior experience completing submissions through 510(k) regulatory pathways Strong knowledge of SaMD (Software as a Medical Device), ideally with experience of radiology and AI / Machine Learning Further experience of UKCA and CE marking, as well as working with multi-disciplinary technical teams is advantageous 

The list above is important, but not as important as hiring the right person! So if you don’t meet all of the criteria above, but feel the role is of interest, please apply or get in touch today to discuss further.

So What’s Next?

If you are a Regulatory Affairs Specialist / RA Specialist currently, or looking to harness your career in this direction, and would like to know more about this excellent opportunity; apply now for immediate consideration!

Regulatory Affairs Specialist, RA Specialist, FDA, 510 K, SaMD, Remote, COR5716
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