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Senior Specialist Medical Device

Address: Bengaluru, Bengaluru, KA 560066, India

Job ID: R0260458

Location Type:

Job Overview

Fresenius Medical Care serves around 292,000 dialysis patients worldwide and provides products in more than 140 countries. We are a vertically integrated medical technology (MedTech) and healthcare service company made up of three operating segments: Care Delivery, Value-Based Care, and Care Enablement. This structure allows us to provide the full spectrum of healthcare services, systems, devices, technologies, products, and pharmaceuticals to deliver high-quality care to people living with kidney disease.

A healthcare worker in protective clothing holds hands and smiles at an older patient receiving medical treatment, while another patient sits nearby in a clinic setting.

Job Description

  • 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.

Care in every moment.
Connection in every step.

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