Regulatory Affairs Professional
GurugramFull-time6–8 yrsPosted over a month ago
Senior pharma role at Siemens Healthineers in Gurugram. Needs 6–8 years and a B.Tech, B.E. or B.Sc.
About the role
Regulatory Affairs Professional at Siemens Healthineers. This position is primarily to support for ensuring pre-market & post-market regulatory compliances for import/ manufacture of Medical devices and IVD devices under….
What you'll do
- This position is primarily to support for ensuring pre-market & post-market regulatory compliances for import/ manufacture of Medical devices and IVD devices under…
- This position will also support in fulfilling the regulatory requirements for these devices in zone countries of Bangladesh, Sri Lanka, Nepal, Bhutan & Maldives
- Perform post market surveillance compliance & reporting requirements for the registered devices
- Coordinate with service & logistics teams for the Field Safety Corrective Actions implemention
- Evaluate, apply & obtain approvals for the Product Change Notifications for registered devices
What you need
- Regulatory affairs
- Documentation
- Communication