This role provides end-to-end ownership for the biological safety of patient-contacting MRI products across their full lifecycle
Job Summary
This role provides end-to-end ownership for the biological safety of patient-contacting MRI products across their full lifecycle.
The successful candidate will lead the execution of Biological Safety Evaluations ensuring alignment with ISO 10993 and global regulatory requirements.
Candidates must possess strong communication skills to articulate complex scientific concepts to both technical and non-technical stakeholders.
Matching Summary
This role provides end-to-end ownership for the biological safety of patient-contacting MRI products across their full lifecycle.
Skills & Requirements
Must-have
ISO 10993 biocompatibility standards
Biological Evaluation Plan authorship
Biological Evaluation Report creation
Toxicological risk assessment expertise
GLP laboratory coordination
FDA and MDR regulatory knowledge
Nice-to-have
Strong stakeholder management skills
Cross-functional team leadership
PhD in Engineering or Science
Formal toxicology training
Experience with GB/T standards
Key Requirements
Master's degree in Engineering or Science
5-7+ years experience in biocompatibility evaluations