Medical Device Regulatory Consultant for MDR / EUDAMED / CE Compliance
We are looking for an experienced Medical Device Regulatory Consultant to support several compliance tasks for our CE-marked device. Scope of Work ============ - UDI & EUDAMED: Guidance on UDI assignment, data preparation, and EUDAMED registration. - System/Procedure Packs: Support with MDR Article 22 requirements and labeling rules. - Technical File Updates: Help us update our Technical File after recent modifications and ensure MDR conformity. - EU Market Entry Requirements: Advise on required documents for customs, distributors, hospitals, and authorities. Required Expertise ============== - Strong knowledge of EU MDR 2017/745. - Experience with UDI, EUDAMED, system/procedure packs. - CE marking and Technical File preparation. - Familiarity with ISO standards (ISO 13485, ISO 14971). - Prior experience supporting manufacturers with EU market placement. - Strongly preferable to have experience with FDA approval process, since we are heading to the US after Europe and need to continue working with the same consultant.Apply Now
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