Carlsmed is seeking an experienced Regulatory Affairs Manager looking to join a progressive, early stage MedTech startup. Our mission is to utilize data to create personalized surgical plans and medical devices to greatly improve the standard of care for debilitating conditions. As RA Manager, you will work on regulatory projects related to proprietary implants, instrumentation and software. Responsibilities Write and submit traditional and special 510(k), interface with FDA during review process Advise executive management on regulatory pathways Create regulatory strategy and plans Ensure regulatory requirements are met. Participate in Design Control and Risk Management processes Provide regulato
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