Company:
Novo Nordisk Global Business Services (GBS)

Job Level: 6
Bring life-changing medical devices and combination products to patients faster. In this role, you'll act as a true ambassador for our device portfolio – shaping regulatory strategy, engaging with health authorities and ensuring the quality and speed that turns innovation into approved therapies.

Your recent role
As a Regulatory Professional, you will plan, prepare and submit high-quality files to authorities to achieve quick approvals. You will act as an ambassador for assigned medical devices, device parts of combination products and primary packaging materials – planning, coordinating and executing regulatory tasks for existing device products in accordance with the Global Regulatory Device Strategy, in close collaboration with your manager and colleagues.

Your Key Responsibilities Will Include
Compiling, reviewing and submitting pre-meeting packages for authority meetings, conducting rehearsals and participating in meetings as appropriate
Handling Change Requests (CR), Non-conformities (NC)



and CAPA cases within your area of responsibility
Reviewing device documentation, protocols and reports, and assessing the appropriateness of scientific and technical documentation for specific regulatory purposes
Archiving and retrieving documentation in our current archiving system (Vault RIM)
Actively participating in Device core groups (development, production and launch coordination, product maintenance) and Global Regulatory Teams (GRTs)
Representing Regulatory Affairs in Notified Body and Health Authority audits

Your new department
In Research & Development, you'll be part of a unit that explores bold scientific ideas and advances them into clinical testing. We combine curiosity, AI tools, and human data to develop transformative therapies. Through collaboration and operational excellence, we shape and deliver an cutting-edge pipeline to meet future patient needs.

RA Device and Digital Health

📌 Regulatory Professional Ii Bengaluru East (Bangalore East)
🏢 Novo Nordisk
📍 Bangalore East