Are you ready to take your career to the next level? Novo Nordisk, a global leader in healthcare, is seeking a Regulatory Professional I to join their dynamic team in Bangalore, Karnataka. This is an incredible opportunity for those passionate about regulatory affairs, particularly in the field of medical devices and drug-device combination products.
Job Description
As a Regulatory Professional I, you will be pivotal in ensuring the highest quality regulatory submissions to authorities. Your main responsibilities will encompass:
- Planning, preparing, and submitting regulatory files efficiently to achieve fast approvals.
- Acting as an ambassador for assigned medical devices and combination products.
- Compiling, reviewing, and submitting Technical Documentation and submission packages.
- Handling Change Requests (CR) and CAPA cases within your area of responsibility.
- Actively participating in Device core groups, development, production, and product launch coordination.
- Representing regulatory affairs during Notified Body and Health Authority audits.
Key Responsibilities
- Compile, review and submit high-quality technical documentation and submission packages.
- Participate actively in meetings and cross-functional collaboration.
- Assess the appropriateness of technical/scientific documentation for regulatory purposes.
- Archive and retrieve documentation in the current archiving system effectively.
Qualifications
To qualify for the Regulatory Professional I position, candidates must have:
- Over 5 years of experience in regulatory affairs related to medical devices or drug-device combinations.
- A Graduate or Post Graduate degree in Pharma, Biomedical, or Engineering disciplines.
- Hands-on experience with regulatory submissions, change management, and post-market changes.
- In-depth knowledge of the Medical Device Regulation (MDR) and current standards.
- Familiarity with Software as Medical Device (SaMD) and experience in Notified Body audits is a plus.
- Strong collaborative skills to work effectively with diverse teams in a hybrid setup.
About Novo Nordisk
Novo Nordisk has been a frontrunner in the healthcare industry for over 100 years, dedicated to driving change for serious chronic diseases. Situated at the heart of diabetes care, the company is expanding its commitment to impact millions of patient lives. With a global workforce of over 63,000 employees, Novo Nordisk prides itself on its collaborative work environment, focusing on unique skills and perspectives that foster innovation and excellence. Join Novo Nordisk and become part of a team that is changing lives together.
How to Apply
