Regulatory Affairs Professional

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

• 6–8 yrs of experience
• Regulatory affairs
• Documentation
• Communication
• B.Tech or B.E. or B.Sc or B.Pharm