Regulatory Affairs Lead

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 quality in RIM and related systems, ensuring completeness, accuracy and audit readiness of registration and licence records, in line with global SQR data standards and governance
• Grow the regulatory scope executed from Bangalore in line with the global SQR operating model – capability mapping, knowledge transfer, training and qualification of staff, and steady-state execution to global standards
• Define and track quality, timeliness and compliance metrics for the team’s deliverables, and drive standardisation, harmonisation, automation and continuous improvement of global regulatory processes
• Act as a trusted functional partner and escalation point for global RA leadership, Quality, R&D, Supply Chain and Commercial teams, and represent the Bangalore team in global regulatory forums
• Support internal and external audits and inspections (Notified Body, MDSAP, FDA) and ensure inspection-ready documentation at all times