Senior Specialist Medical Device
Fresenius Medical Care · Bengaluru · onsite · Posted 53d ago
Not disclosedFresherfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling
- Ensure compliance with regulatory standards and testing requirements throughout product design and development
- Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities
- Ensure global regulatory product availability aligned with commercial strategy by managing registrations, renewals, and submissions
- Coordinate regulatory product strategies
- Lead regulatory aspects of product and process changes, including regulatory documentation.
Sourced from foundit
Skills
regulatory product strategiesLabelingregulatory documentationregulatory approvalsTesting requirementsChange notificationsIFUsRegistration dossiersRegulatory product documentationTechnical files
About Fresenius Medical Care
Fresenius Medical Care
Healthcare
201
employees
1996
30 years old
Massachusetts
United States
₹8.2L PA avg
Avg at Fresenius Medical Care
About
Innovative products, therapies and services creating a future worth living for our patients. Chronic and acute kidney dialysis and therapeutic apheresis.
Industries
Healthcare
Employee ratings
10 reviews
3.6/ 5
Culture
3.2
Career growth
2.5
Work-life
3.4
Employees rate it well for
Job Security37Overall Company36
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