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Regulatory Specialist and Senior Specialist
3 months ago
Regulatory Affairs Specialist - Fully Remote This is an excellent Regulatory Affairs Specialist, working for a company with a growing reputation in their field. The successful Regulatory Affairs 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 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, include:
~ Fully Remote working - With options to go into the office if you want to
~25 days holiday + bank holiday
~ 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 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
