EU Regulatory Affairs Manager - MDR & CE Marking

Genesis Medtech Group is seeking a Regulatory Affairs (RA) Manager for Europe to oversee market access and lifecycle management of surgical devices within the EU. Key responsibilities include managing CE certification, authoring technical documentation, and developing clinical evaluation reports. Ideal candidates will have a Bachelor's or Master's degree in a relevant field, at least 8 years of experience in Medical Device Regulatory Affairs, and fluency in English. This role entails collaboration with teams across multiple time zones.
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