Quality & Regulatory -Manager

6 - 10 years

10 - 18 Lacs

Posted:1 week ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Required Attributes :

  • Masters 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.

Email : monisha.lahiri@randstad.in

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Randstad

Staffing and Recruiting

Atlanta GA

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