Regulatory Specialist and Senior Specialist

4 weeks ago


United Kingdom Corriculo Recruitment Full time

Regulatory Affairs Specialist - Fully Remote 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 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.

Some of the benefits on offer for the Regulatory Affairs Specialist / RA Specialist, include:
~ Fully Remote working - With options to go into the office if you want to
~25 days holiday + BH
~ 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
IEC 62304, IEC 82304) and other international regulatory requirements.
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



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