...their experience considering the rapid nature of updates/changes in the regulatory landscape, the device, its functionalities, and the therapy area.
Preferred Experience:
1. Significant experience writing s...
...hand as there is an exciting opportunity waiting for you as “RA Specialist” with us. "Apply now" - At Novo Nordisk, we assure you will... ...SME for the defined area of responsibility. Mentor...
...environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as “Senior Regulatory Professional” with us. "Apply now" - At Novo Nordisk, we assure you will exp...
...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...
...Device Regulation (EU MDR) and various FDA guidance Pre-market submission guidelines, General Principles of Software Validation, Off The Shelf (OTS a.k.a SOUP) software use, Software as a Medical Device: Clinical Ev...
...devices. You will collaborate with cross-functional teams including engineers, software developers, and clinicians to ensure that the electrical and electronic aspects of medical devices meet quality, safe...
Collaborate closely with cross-functional teams including software engineers, UX/UI designers, product managers, and regulatory experts to gather information and understand product specifications.
Create user-centric documentation for UI applica...
Role : Regulatory Manager
Work Location : Bangalore
Key Responsibilities & Accountabilities (Tasks & Deliverables):
General and Task... ...Provides leadership and guidance (including training) t...
...Job Title: QARA Specialist
Job Role :
The Quality and Regulatory Affairs (QARA) Specialist will provide leadership in the quality and regulatory affairs function to understand regulatory requirements of medic...
...Medical Device Regulatory Affairs Job duties of a Regulatory Affairs Specialist include:
Developing and implementing regulatory strategies for new and existing products
Preparing and submitting regulatory documentation t...
