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Specialist-Medical Systems Products

Fresenius Medical Care

Bengaluru, KA, IndiaFull-timePosted 1w agoStill listed 3 days ago

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At a glance

Compensation
No compensation found
Location
Bengaluru, KA, India
Schedule
Full-time
Work Authorization
Not specified

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Job overview

The role involves authoring CERs and related documents, supporting risk management on medico‑regulatory topics, participating in cross‑functional teams, authoring assessments for product development, and planning medico‑scientific activities to generate clinical evidence in close alignment with the therapy field director and clinical research teams.

Skills & qualifications

RequiredNice to have

Skills

Risk ManagementMedical Regulatory KnowledgeClinical Data AnalysisMedical Evidence DevelopmentCross Functional CollaborationClinical Research Planning

Full job description

PRINCIPAL DUTIES AND RESPONSIBILITIES: Authorship of CERs and related documents in close alignment with the director of the respective therapy field Supportive function in risk management, in particular concerning medico-regulatory topics: Provide support in the development, maintenance and updating of documents related to risk management deliverables Participation in cross-functional teams for medical-regulatory aspects Authorship of assessments concerning product development issues, in analysis of clinical data and in defining the medical evidence needed for driving or improving product development processes in close collaboration with the therapy field director Planning and support of medico-scientific activities related to generation of clinical evidence (studies) in close alignment with the respective director and Clinical Research

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