The Senior Regulatory Affairs Specialist is responsible for managing medical device regulatory activities in India to ensure timely market access, ongoing regulatory compliance, and uninterrupted product supply
Job Summary
The Senior Regulatory Affairs Specialist is responsible for managing medical device regulatory activities in India to ensure timely market access, ongoing regulatory compliance, and uninterrupted product supply.
Monitor and communicate regulatory intelligence and assess impact; maintain regulatory documentation and databases, utilize Regulatory Information Management Systems (Veeva RIM).
At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement.
Matching Summary
The Senior Regulatory Affairs Specialist is responsible for managing medical device regulatory activities in India to ensure timely market access, ongoing regulatory compliance, and uninterrupted product supply.
Skills & Requirements
Must-have
India medical device regulatory activities
India MDR 2017 compliance
ASEAN regulatory frameworks
post-market regulatory activities
Veeva RIM
Nice-to-have
continuous improvement culture
innovating at the speed of life
transforming human health
proactively mitigate regulatory risk
Key Requirements
minimum 3 years of RA experience
Experience with India CDSCO submissions
Bachelor’s Degree/ Diploma in Life Sciences, Engineering or other related discipline