Regulatory Professional I

Job description

**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, youll 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. Youll work very closely with colleagues in Denmark and in our affiliates all over the world making Regulatory Affairs truly interesting and challenging.