RAQA Specialist
BengaluruFull-time8–10 yrsPosted 1 week ago
Senior consulting role at Intuitive in Bengaluru. Needs 8–10 years and a degree.
About the role
The Regulatory Affairs Specialist supports the department by converting/creating the Medical Device Technical Documentation according to the India Medical Device Rules, evaluating medical device changes, determining and executing registration strategy and ensuring compliance of marketing material according to internal processes
What you'll do
- Prepares and submits medical device technical documentation according to India Medical device rules requirements
- Assesses the regulatory impact on the development of new devices or the changes to existing products
- Coordinates registration strategy with sales/marketing stakeholders
- Prepares and submits Medical Device registration dossiers for assigned geographies and ensures accurate records
- Replies regulatory inquiries to key stakeholders (e.g. Customer Service, Contract/Tender, Sales)
What you need
- PowerPoint
- Excel
- Regulatory affairs
- Process improvement