Regulatory Professional II

Category:Reg Affairs & Safety Pharmacovigilance

Location:Bangalore, Karnataka, INCompany: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 new role
- As a Regulatory Qualified, 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

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