Job Description
EU MDR Specialist - R&D Engineer
Job Description
We are seeking an experienced R&D Engineer with deep expertise in the EU Medical Device Regulation (EU MDR 2017/745) to join our team. This role will support the design, development, documentation, and compliance strategy for medical devices intended for the EU market. The ideal candidate has a strong engineering foundation combined with hands-on experience navigating EU MDR requirements throughout the product lifecycle. As part of the R&D organization, you will collaborate closely with Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing to ensure that products meet both technical performance expectations and global regulatory obligations.
Responsibilities
+ Lead and support remediation design activities for medical devices in accordance with EU MDR.
+ Conduct engineering studies, testing, and technical evaluations, ensuring design controls are fully aligned with regulatory requirements.
Job Description
We are seeking an experienced R&D Engineer with deep expertise in the EU Medical Device Regulation (EU MDR 2017/745) to join our team. This role will support the design, development, documentation, and compliance strategy for medical devices intended for the EU market. The ideal candidate has a strong engineering foundation combined with hands-on experience navigating EU MDR requirements throughout the product lifecycle. As part of the R&D organization, you will collaborate closely with Regulatory Affairs, Quality Assurance, Clinical, and Manufacturing to ensure that products meet both technical performance expectations and global regulatory obligations.
Responsibilities
+ Lead and support remediation design activities for medical devices in accordance with EU MDR.
+ Conduct engineering studies, testing, and technical evaluations, ensuring design controls are fully aligned with regulatory requirements.
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