健康医学硬件工程师
Core
End-to-end management of clinical trials and regulatory certification for medical hardware products.
Role type
Senior regulatory and clinical delivery engineer (medical hardware)
Builds
Medical devices ready for clinical trials and regulatory approval
Domain
Medical hardware / Regulatory affairs / Clinical research
Deliverable
client delivery
Required skills
Clinical trial end-to-end delivery, Regulatory certification management, Clinical study design, Medical safety standards establishment, CRO management, Regulatory documentation preparation
Preferred skills
Materials engineering for wearable/flexible textiles, Biocompatibility research, Biomedical engineering background, Medical device industry experience
Technologies
None stated
Responsibilities
Manage clinical trial delivery from CRO selection to final delivery, Prepare and manage regulatory certification applications and documentation, Establish medical safety standards for devices, Design clinical study protocols