Fresenius Medical Care

Operates dialysis facilities and renal care

Senior Specialist Medical Device

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeBengaluru, Karnataka, IndiaNo salary listedIn-person

About the Job

Responsibilities

Manage global regulatory product documentation, including technical files, registration dossiers, instructions for use, 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.

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.

About the Company

Fresenius Medical Care

Operates dialysis facilities and renal care

Fresenius Medical Care North America provides renal care through a network of dialysis facilities and outpatient cardiac and vascular labs that deliver coordinated treatment for chronically ill patients. It also offers specialty pharmacy and laboratory services and manufactures and distributes dialysis equipment, disposables, and renal medicines. The company stands out by being the world’s largest fully integrated renal care provider with an extensive network that covers care delivery, drug and lab services, and product supply. Its goal is to ensure access to comprehensive, high-quality care for people with kidney and other chronic conditions across North America.

Company size: 11-50
Company stage: Late Stage VC
Total funding: $40.2M
Headquarters: Waltham, MA
Founded: 1996

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