Regulatory Affairs Expert

Fresenius Medical CareHebbal, BangalorePosted 2 months ago

Lead or staff
Full time
8 to 10 years

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About the role

Fresenius Medical Care develops medical devices and health software. The Regulatory Affairs Expert manages global product registrations, compliance documentation, and regulatory strategy for cloud-hosted medical software.

What you'll do

Manage global technical files, registration dossiers, instructions for use, and labeling
Ensure regulatory compliance throughout product design and development
Coordinate approvals and change notifications with authorities and notified bodies
Manage registrations, renewals, and submissions to support global product availability
Assess regulatory impact of product, process, software, and cloud infrastructure changes
Lead regulatory strategy for cloud-hosted medical software

Skills

Must have

Regulatory affairs
Medical device regulations
Regulatory submissions
Regulatory documentation
Quality management
Risk management
Cybersecurity
Data protection
Cloud compliance

Who it's for

Education: Master's degree
Degree: technical, engineering, scientific
Experience: 8 to 10 years
Languages: english
Domain: healthtech medical devices

About Fresenius Medical Care

Fresenius Medical Care has 35 open roles in Bangalore, at Fresenius Medical Care Global Business Services (GBS) Bangalore. See every Fresenius Medical Care role.