Senior Regulatory Affairs (RA) Specialist
BengaluruFull-time5–9 yrsPosted 1 week ago
Senior pharma role at HealthMinds Consulting in Bengaluru. Needs 5+ years.
About the role
Regulatory Affairs Specialist will support the development and execution of global regulatory strategies for medical devices and combination products. role is responsible for preparing regulatory submissions, maintaining product registrations, supporting product lifecycle activities, and ensuring compliance
What you'll do
- Support the development and
- Implementation of regulatory strategies for medical devices and
- Combination products across global markets
- Prepare, compile, review, and
- Maintain regulatory submissions including FDA 510(k), PMA, De Novo, EU MDR
What you need
- Regulatory affairs
- Documentation
- Technical writing
- Internal audit
- Communication