Job Opportunity For Consultant, Regulatory At PATH In India, Remote New Delhi

Scope of work:

• Regulatory support on taking the academic or commercial route for performing study of the medical device in India taking into consideration the status of study sites.
• Prepare regulatory application checklist for submission to regulatory authorities.
• Submit regulatory dossier, subsequent query resolution, and follow up.
• Liaison and follow up with regulatory authorities, frequent follow ups
• Device Master File Preparation and Maintenance
• Regular intimation of the development of submitted application
• Registration of ethics committee at the sites (if required)
• Prepare pre-requisite documents for ethics committee approval (if required)
• Trial related update submissions, submissions to Ethics Committees and applicable regulatory bodies
• Regulatory/Quality Analysis
• Providing support and working in collaboration with PI’s at all sites
• Assistance with device labelling requirements
• Updating for the new guidelines and changes if any in the current procedure or regulations.
• Handling queries raised by respective authorities & assistance in providing appropriate response to the same
   

Location: Rem

1. PATH is dedicated to building an inclusive workforce where diversity is valued.
2. PATH is an equal opportunity employer. Every qualified applicant will be considered for employment.
3. PATH does not discriminate based on race, color, religion, caste, gender, sexual orientation, gender identity, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
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