Charge Registered Nurse - RN
freseniusmedicalcare
RA Lead- Regulatory Affairs, SQR
freseniusmedicalcare· INSC IND GBS India
About this role
- 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
Frequently Asked Questions
Is the salary disclosed for the RA Lead- Regulatory Affairs, SQR position at freseniusmedicalcare?
The salary for this RA Lead- Regulatory Affairs, SQR role at freseniusmedicalcare is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the RA Lead- Regulatory Affairs, SQR position at freseniusmedicalcare located?
This RA Lead- Regulatory Affairs, SQR role at freseniusmedicalcare is based in Bengaluru, KA. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the RA Lead- Regulatory Affairs, SQR role at freseniusmedicalcare full-time or part-time?
This is listed as a Full time position. It is posted as a RA Lead- Regulatory Affairs, SQR role in the INSC IND GBS India department at freseniusmedicalcare.
Which team or department does the RA Lead- Regulatory Affairs, SQR at freseniusmedicalcare belong to?
This RA Lead- Regulatory Affairs, SQR position is part of the INSC IND GBS India department at freseniusmedicalcare. See the full job description for more information about the team structure and responsibilities.
How do I apply for the RA Lead- Regulatory Affairs, SQR position at freseniusmedicalcare?
Click the "Apply Now" button on this page. You will be redirected to freseniusmedicalcare's official application portal hosted on workday where you can submit your application directly.
When was the RA Lead- Regulatory Affairs, SQR job at freseniusmedicalcare posted?
This RA Lead- Regulatory Affairs, SQR position at freseniusmedicalcare was posted on Sep 17, 2026. Apply as soon as possible — early applications are often reviewed first.
RA Lead- Regulatory Affairs, SQR
freseniusmedicalcare
You'll be redirected to freseniusmedicalcare's official application page on Workday.