R&D Engineer

Duties:Write, analyse, and review all technical documentation to support country-specific regulatory requirements (e.g., Europe, USA, Canada, China) including, but not limited to, design verification and validation protocols and reports, risk management files, usability protocols and reports, manufacturing process information, biocompatibility assessment reports, labelling content, list of applicable standards, and list of general safety and performance requirements - all in close collaboration with the team and with guidance from key cross-functional partners;Plan and provide assessments of medical device documentation in support of international certifications (e.g.
EU, FDA, HC, NMPA).Collaborate with the team manager and team leader to define regulatory strategies and ensure alignment of timelines for updating technical documentation.Raise the level of quality and define future standards for documentation;Ensure alignment of design verification and validation activities within the project and organization;Support new product development and support the team to assure collection of appropriate data for regulatory compliance.Other duties as assigned.
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