Job Summary

Sr Regulatory Professional

Company: Novo Nordisk Global Business Services (GBS)

Job Level: 7

Are you ready to shape the regulatory future of medical devices and combination products that reach patients around the world? Join us as a Senior Regulatory Professional and play a pivotal role in securing fast, high-quality approvals that bring life-changing therapies to those who need them most.

Your new role

As a Senior Regulatory Professional, you will plan, prepare and submit high-quality files to authorities to achieve fast approvals, while acting as an ambassador for assigned medical devices and device parts of combination products. You will serve as a Subject Matter Expert (SME) for your defined area of responsibility, mentoring colleagues and providing technical sparring to project teams on device regulatory pathways all in close collaboration with your manager and peers, and in alignment with the Global Regulatory Device Strategy.

Day-to-day your tasks will include:

- Compiling, reviewing and submitting Technical Documentation/CTD and submission packages, and participating in meetings as appropriate
- Handling Change Requests (CR) within your area of responsibility, preparing Regulatory Strategies and leading/participating in Health Authority Interactions
- Reviewing device documentation, protocols and reports, and assessing the appropriateness of scientific/technical documentation for specific regulatory purposes
- Archiving and retrieving documentation in the current archiving system, and representing RA in Notified Body and Health Authority Audits
- Actively participating in Device core groups (development, production and launch coordination, product maintenance) and Global Project Teams
- Mentoring and providing technical sparring to project teams on device regulatory pathways

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, made up of high-calibre regulatory professionals. The team's objective is to offer core RA competencies that enable Novo Nordisk to secure fast, high-quality product and device approvals, delivering full strategic and operational support on a global scale across the value chain. We provide regulatory expertise in CMC, Medical Devices and Combination Products, working closely with colleagues in Denmark and across our global affiliates making Regulatory Affairs a truly engaging and challenging place to grow your career.

Your skills qualifications

We're looking for a Senior Regulatory Professional who thrives in a global, cross-cultural environment and brings deep regulatory expertise in medical devices and combination products. You'll bring with you:

- More than 8 years' experience in a related field, along with a Graduate or Post Graduate Degree in Pharma, Biomedical or Engineering (preferred)
- Proven experience handling regulatory submissions of medical devices or drug-device combination products across the globe, including post-market changes
- Mandatory knowledge of MDR and current standards, with experience preparing Regulatory Strategies for post-market changes, global roll-outs and direct interaction with Health Authorities highly preferred
- Knowledge of Software as a Medical Device (SaMD) and exposure to Notified Body audits and interactions as an added advantage
- Strong ability to collaborate cross-functionally with teams and stakeholders from different backgrounds and cultures in a hybrid setup
- Excellent communication skills and fluency in English

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.

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