Regulatory Affairs Lead

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 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
• Represent Regulatory Affairs within the SQR leadership team in India and work enabling functions on workforce planning, hiring, engagement, retention and site-level matters, while functional ownership of the work remains with global SQR

Your Profile:

• Bachelor’s degree in Life Sciences, Pharmacy, Biomedical or Biotechnology Engineering, or a related field; advanced degree preferred
• 10-14 years of Regulatory Affairs experience in medical devices, IVD, combination products or pharmaceuticals, including at least 5 years leading and developing teams
• Hands-on experience with international registrations and submissions - EU MDR/IVDR technical documentation, U.S. FDA 510(k), and LATAM, APAC and MEA country registrations
• Working knowledge of ISO 13485, ISO 14971, 21 CFR Parts 820/QMSR and 803, MDSAP and applicable regional device regulations
• Experience working in a global capability centre or an offshore team that is functionally directed by a global organisation, including building capability and scaling scope, is strongly preferred
• Proficiency with regulatory information management and document systems (e.g. Veeva Vault RIM, SAP, PLM) and reporting tools such as Power BI
• Demonstrated ability to set performance standards, track quality and timeliness metrics and drive process improvement; Lean or Six Sigma exposure is an advantage
• RAC certification or equivalent is desirable
• Excellent written and verbal communication in English, with proven stakeholder management in a global matrix across multiple time zones
• Strong people leadership, talent development and change management skills, with high integrity and a patient-first mindset

Our offer:

There is a lot you can discover at Fresenius Medical Care. No matter which field you are an expert in and how much experience you have, all dedicated to your professional journey.

• Whether in front of or behind the scenes - you are helping to make ever better medicine available to people around the world
• Individual opportunities for self-determined career planning and professional development
• A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
• Modern office location with hybrid work set up. We are located in Hebbal, Bangalore.
• You will be entitled to healthcare, insurance and transportation benefits