SQR:
Systems, Quality & Regulatory (SQR), a global function within Care Enablement ensuring Fresenius Medical Care’s products meet the highest standards of quality, safety, and regulatory compliance throughout the entire product lifecycle. The team supports market access, innovation, and patient safety by driving excellence across manufacturing and supply chain, overseeing post-market surveillance, and promoting continuous improvement and system harmonization. SQR also manages regulatory and quality data governance and provides critical product-related business services across global operations. Join our passionate team and help shape healthcare worldwide

Your role:
As Manager, Regulatory Affairs, you will build and lead the hosted Regulatory Affairs team based at our Global Business Services (GBS) campus in Bangalore. You will be accountable for regulatory deliverables across Fresenius Medical Care’s global product portfolio as a full member of the global SQR team.
- Build, lead and develop a high-performing Regulatory Affairs team-recruitment, onboarding, coaching,



performance management and succession planning, in partnership with global SQR leadership and GBS enabling functions
- Hold end-to-end accountability for regulatory deliverables as an integral part of the global and regional RA teams: registration dossiers, technical documentation, submissions, renewals and lifecycle maintenance across the U.S., EU, LATAM, and APAC
- Prepare and maintain technical documentation under EU MDR 2017/745 and IVDR 2017/746, including inputs to clinical evaluation and post-market surveillance documentation
- Support U.S. FDA submissions (510(k), pre-submissions, letters to file) and international country registrations, license renewals and legalisation requirements
- Assess design, labeling and manufacturing changes for regulatory impact and determine notification and submission requirements together with R&D;, Quality and Operations
- Own regulatory data governance and data q

📌 Regulatory Affairs Lead (Bengaluru)
🏢 Fresenius Medical Care
📍 Bengaluru