Roles and Responsibilities
- Stay updated 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.
- Function with utmost sensitivity towards data confidentiality and privacy.
- Perform additional duties as assigned by the supervisor, including up to 25% time for other activities.
