Senior Regulatory Lead

2 weeks ago


Gurgaon, Haryana, India Boston Scientific Full time

Key Responsibilities

As a member of the Regulatory Affairs team at Boston Scientific, you will be responsible for ensuring compliance with regulatory requirements for medical devices in India. This will involve compilation of Medical Device Dossiers, regular follow-ups with CDSCO, and work with other regulatory authorities. You will also be responsible for creating frameworks for medical write-ups and executive summaries, addressing technical queries, and managing change. Additionally, you will support the acquisition team with submissions and follow-ups, and prepare technical literature for Subject Expert Committee meetings.

Requirements

  • Graduate/Postgraduate in life sciences or engineering
  • 8+ years of experience in regulatory affairs


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