Regulatory Professional I

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 new 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 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.

Your skills & 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 AMDR 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

Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations.

What we offer
There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.

Deadline

23 July 2026. Applications are reviewed on an ongoing basis, so please apply as soon as possible.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.