Regulatory Affairs Manager

6 - 11 years

4 - 9 Lacs

Posted:2 days ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Job Title:

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Job Overview:

Documentation Officer / Manager

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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