Regulatory Affairs Manager

2 weeks ago


Faridabad, Haryana, India Polymed Full time ₹ 4,00,000 - ₹ 12,00,000 per year

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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