Medical Device Regulatory Consultant for MDR / EUDAMED / CE Compliance
We are looking for an reputed company Medical Device Regulatory Consultant to support several compliance tasks for our CE-marked device.
Scope of Work
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- 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
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- 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 reputed company consultant.
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