Regulatory Affairs Lead - SQR
About the job
- Build, lead, and develop a high-performing Regulatory Affairs team through 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 Regulatory Affairs teams, including 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, including 510(k)s, pre-submissions, and letters to file, as well as 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 through 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 Regulatory Affairs 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, including Notified Body, MDSAP, and FDA inspections, and ensure inspection-ready documentation at all times.
- Represent Regulatory Affairs within the SQR leadership team in India and work with enabling functions on workforce planning, hiring, engagement, retention, and site-level matters, while functional ownership of the work remains with global SQR.
About the company
Fresenius Medical Care North America runs a network of dialysis facilities and outpatient labs to deliver coordinated kidney care for hundreds of thousands of patients. It also offers specialty pharmacy and laboratory services and manufactures a wide range of dialysis equipment, disposables, and renal drugs. The company treats patients by providing dialysis and related care at its clinics, supported by the equipment, supplies, and medicines it develops and distributes. FMCNA differentiates itself through its size and integration as the world's largest fully integrated renal company, with a nationwide network covering care delivery, drugs, labs, and manufacturing, aiming to provide high-quality, convenient access to comprehensive services across North America.
Company Size
11-50
Company Stage
Late Stage VC
Total Funding
$40.2M
Headquarters
Waltham, Massachusetts
Founded
1996
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Simplify's Take
What believers are saying
- Q2 2026 operating income rose 23%, showing transformation gains reached profitability.
- FME25+ delivered EUR 67 million savings in Q2 2026 and targets EUR 1.2 billion.
- Real-world evidence studies in July and August 2026 strengthen high-volume hemodiafiltration adoption.
What critics are saying
- The August 2026 outlook disappointed investors after dialysis growth stalled and shares fell 10%.
- FME25+ closed around 100 U.S. clinics in 2026, risking patient leakage to DaVita.
- AB 290 litigation and premium-assistance rules threaten U.S. reimbursement economics and legal spend.
What makes Fresenius Medical Care unique
- Fresenius Medical Care controls dialysis care, equipment, labs, and specialty pharmacy end-to-end.
- Its 5008X CAREsystem reached around 100 clinics and 100,000 treatments by May 2026.
- kinexus and TherapyWise deepen its software moat across home dialysis and kidney therapy.
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Benefits
- Professional Development Budget
- Conference Attendance Budget
- Flexible Work Hours