RA Lead- Regulatory Affairs, SQR

Fresenius Medical Care develops medical products and services, with this team handling regulatory affairs across global markets. The lead will manage the Bangalore team and oversee regulatory submissions, documentation, registrations, data quality and audit readiness.

• Recruit, onboard, coach and develop the Regulatory Affairs team
• Oversee registration dossiers, technical documentation, submissions and renewals across regions
• Prepare EU MDR and IVDR documentation and support FDA submissions
• Assess regulatory impact of design, labeling and manufacturing changes
• Maintain regulatory data quality and audit-ready registration records
• Develop Bangalore regulatory capabilities and improve global processes

Domain

medical devices

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