Regulatory Affairs Manager
2 weeks ago
Job Title: Manager (RA)
Location: Faridabad
Department: Regulatory Affairs (RA)
Job Overview:
We are seeking a meticulous Documentation Officer / Manager to manage regulatory documentation and ensure compliance with ISO 13485, EU MDR, FDA, and other regulatory standards.
Key Responsibilities:
- Prepare, maintain, and review regulatory documentation as per ISO 13485, EU MDR, and FDA requirements.
- Support regulatory audits, inspections, and compliance activities.
- Ensure all documentation is accurate, complete, and up-to-date.
- Liaise with cross-functional teams (QA, Production, R&D) to gather necessary information for submissions.
- Maintain document control systems and track regulatory submissions and approvals.
- Assist in preparing dossiers for product registration, approval, and compliance.
- Monitor changes in regulatory requirements and update documentation processes accordingly.
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