Regulatory Professional I (Bengaluru)

Regulatory Professional I (Bengaluru)

13 Aug
|
Novo Nordisk
|
Bengaluru

13 Aug

Novo Nordisk

Bengaluru

Company: Novo Nordisk Global Business Services (GBS)

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 current role
As a Regulatory Professional, you will plan, prepare and submit high-quality files to authorities to achieve fast 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 innovative pipeline to meet future patient needs.

RA Device and Digital Health is part of R

📌 Regulatory Professional I (Bengaluru)
🏢 Novo Nordisk
📍 Bengaluru

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