Job Description
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 tot his job
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