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Quality Regulatory Manager

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Randstad

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Location:
India , Bengaluru

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Contract Type:
Not provided

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Salary:

Not provided
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Requirements:

  • Master’s degree/Ph.D in Biomedical Engineering, Life Sciences, Biotechnology, or a related field
  • 6-10 years of experience in regulatory affairs and quality management within the IVD or medical device industry
  • In-depth knowledge of global regulatory standards and quality management systems, including ISO 13485, ISO 14971, EU IVDR, US FDA 21 CFR 820, and CDSCO
  • Proven experience in leading regulatory submissions and successful product registrations in international markets (EU, US, India, etc.)
  • Experience in managing audits, including Notified Body inspections, CDSCO/FDA audits, and internal audits

Additional Information:

Job Posted:
January 05, 2026

Expiration:
January 26, 2026

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