This job offer is not available in your country.
Regulatory Affairs Specialist
ConfidentialBengaluru / Bangalore8 days ago
Job descriptionBachelor's degree and two years of related experience, or six years of regulatory experience Demonstrated knowledge of regulatory affairs Proficiency in relevant computer applications such as spreadsheets, word processing, and database tools Strong organizational skills, self-motivation, and attention to detail
Main Job Tasks and Responsibilities :
- Coordinate and prepare document packages for regulatory submissions (domestic and international)
- Facilitate corrective actions for internal audits
- Assist during governmental inspections and support related documentation
- Coordinate activities related to recalls and medical device reports
- Prepare documentation for clinical trials in compliance with applicable regulations
- Maintain and update company policies and procedures as required
- Interact, as directed, with various levels of management, external agencies, and companies
- Participate actively on project task teams
- Perform other related duties and tasks as assigned
Education and Experience :
Skills Required
Regulatory Compliance, Clinical Trials, Risk Management
Create a job alert for this search
Regulatory Specialist • Bengaluru / Bangalore