Technischer Redakteur (w/m/d) - Biomechanik
Core
Technical liaison between the biomechanics testing area and the regulatory approval department for joint and spine implants.
Role type
Technical Editor (Regulatory Affairs)
Builds
Technical documentation and regulatory statements for international market access
Domain
Medical technology / Biomechanics / Regulatory Affairs
Required skills
Technical documentation, Regulatory affairs, Gap analysis of standards, Technical communication, Data research and review, Worst case definition, Test planning and organization
Preferred skills
Experience with country-specific regulatory approvals, Digitalization of technical documentation
Technologies
MS-Office
Responsibilities
Prepare and align technical documentation, Communicate biomechanical regulatory tests with internal and international stakeholders, Align approval strategies with internal and external authorities, Answer technical inquiries and create arguments for approval strategies, Research and compile data for conformity assessment of joint and spine implants, Create technical statements for international regulatory authorities, Plan and organize tests for country-specific approvals, Perform gap analyses of standards in biomechanics (hip, knee, spine, materials), Work on digitalization concepts for technical documentation