RA Lead- Regulatory Affairs, SQR

Fresenius Medical Care; Bengaluru; On-site; INR 2,500,000 - 4,200,000; Full time

Job summary

Fresenius Medical Care in Bengaluru is seeking a senior Regulatory Affairs leader to build and guide a high-performing RA team, driving recruitment, onboarding, coaching and performance management, and partnering with global SQR leadership to enable functions.

You will own end-to-end regulatory deliverables across US, EU, LATAM and APAC, maintain EU MDR/IVDR documentation, support FDA submissions, ensure audit readiness and govern RIM data, while expanding Bangalore's scope to meet global

Qualifications

• Build and lead a Regulatory Affairs team with recruitment, onboarding, coaching and performance management.
• End-to-end regulatory deliverables across US, EU, LATAM and APAC.
• Prepare EU MDR 2017/745 and IVDR 2017/746 documentation including clinical evaluation and post-market surveillance.
• Support FDA submissions and international registrations, license renewals and legalization requirements.
• Own regulatory data governance and data quality in RIM and related systems.

Responsibilities

• Grow Bangalore-based regulatory scope in line with global operating model.
• Define and track quality, timeliness and compliance metrics for the team’s deliverables; drive standardisation and automation of processes.
• Act as partner to global RA leadership and represent Bangalore team in global regulatory forums.
• Support internal and external audits and inspections and ensure inspection-ready documentation.

Skills

Team leadership

Regulatory affairs

Regulatory submissions

Cross-functional collaboration

Regulatory data governance

Audits & inspections

Tools

RIM

Quality systems

Job description

• 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