Job Summary

Regulatory Professional II

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 Professional, you will plan, prepare and submit high-quality files to authorities to achieve rapid 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 RA CMC Device in Global Business Services (GBS) Bangalore, a team of high-calibre regulatory professionals offering core RA competencies that enable Novo Nordisk to secure fast, high-quality product and device approvals. The team delivers full strategic and operational support on a global scale across the value chain, providing regulatory expertise in CMC, Medical Devices and Combination Products. You'll work very closely with colleagues in Denmark and in our affiliates all over the world making Regulatory Affairs truly interesting and challenging.

Qualifications

We are looking for a proactive regulatory professional who thrives in a global, cross-cultural environment and brings strong technical expertise in medical devices and combination products. To succeed in this role, you'll bring:

- A graduate or post-graduate degree, with Biomedical or Engineering graduates preferred, and 4-8 years of experience in a related field
- Experience handling medical devices or drug-device combination products, including post-marketing change management
- Solid knowledge of MDR and current standards, with knowledge of Primary Packaging Material DMF, Article 117 of MDR and Drug-Device Combination Products considered an added advantage
- Strong ability to cross-collaborate with teams and stakeholders from different backgrounds and cultures in a hybrid setup
- Excellent written and spoken English communication skills, coupled with a proactive, quality-driven mindset and strong attention to detail

Experience Level

Senior Level

Disclaimer : This job posting & Location has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Regulatory Professional II (Karnataka)
🏢 Novo Nordisk
📍 Karnataka