Regulatory Professional I- Medical Devices

3 days ago

Bengaluru, India Novo Nordisk Full time

**Department: Global Regulatory Affairs**

**About the Department**

Global Regulatory Affairs (GRA) in Global Business Services (GBS) Bangalore is a global RA hub consisting of high calibre regulatory professionals. The objective of the team is to offer core RA competencies enabling NN secure fast, high quality product approvals. The team delivers full strategic and operational support on a global scale across value chain on core regulatory processes across NN product portfolio. We provide regulatory expertise in terms of CMC & Medical Devices, Combination Products and work very closely with our colleagues in RAHQ, Denmark (DK) as well as colleagues in our affiliates all over the world. That makes Regulatory Affairs truly interesting and challenging to work.

**The Position**
- Compile, review and submit pre-meeting packages for authority meetings conduct rehearsal’s and participate in meetings as appropriate.
- Handle Change Requests (CR), Non-conformities (NC) and CAPA cases within area of responsibility.
- Review of Device documentation, protocols and reports within area of responsibility. Assess the appropriateness of scientific/technical documentation for specific regulatory purposes.
- Responsible for archiving and retrieving documentation in current archiving system and will represent RA in Notified Body and Health Authority Audits.
- Active participation in Device core groups (development, production and launch coordination, product maintenance) and GRTs (Global Regulatory Team)

**Experience**
- 6-12 years of experience in related field along with Graduate or Post Graduate Degree, Biomedical and Engineering graduates preferred.
- Experience in handling medical devices or drug device combination products.
- Experience in handling post marketing change management.
- Knowledge on MDR and Current Standards.
- Knowledge on Software as Medical Device is added advantage.
- Ability to cross collaborate and work with the teams and stakeholders from different backgrounds and culture in a Hybrid setup.

**Working At Novo Nordisk**

At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales
- we're all working to move the needle on patient care.

**Contact**

**Deadline**

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

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

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