Regulatory Compliance Specialist at Wadhwani AI
About Company
As a Regulatory Compliance Specialist at Wadhwani AI, you will oversee compliance with FDA, ISO, and EU regulations. This role involves developing and implementing strategies, conducting audits, producing quality documentation, providing improvement recommendations, tracking metrics, and maintaining confidential records.
Position Details
| Position Name | Organization | Qualification | Experience | Salary | Location |
|---|---|---|---|---|---|
| Regulatory Compliance Specialist | Wadhwani AI | Master’s degree in Business Administration, Regulatory Affairs, or Quality Management | 3-4 years | Not disclosed | Delhi |
Roles and Responsibilities
- Stay updated with and understand relevant FDA, ISO, and EU regulatory requirements.
- Interpret and communicate regulatory requirements to internal teams to ensure compliance.
- Develop strategies and procedures to align company practices with regulatory requirements.
- Collaborate with various departments to implement necessary changes for compliance.
- Develop and produce high-quality documentation in compliance with regulatory requirements.
- Conduct regular audits to assess compliance levels and identify areas for improvement.
- Assist in preparing regulatory submissions and responses to queries or audits.
- Analyze data and reports to track compliance metrics and trends.
- Provide recommendations and corrective actions to resolve non-compliance issues.
- Maintain accurate and up-to-date documentation of compliance activities.
- Prepare reports summarizing compliance status, findings, and recommendations for management.
- Ensure data confidentiality and privacy in all activities.
- Perform additional duties as assigned by the supervisor, including up to 25% time for other activities.
