Regulatory Affairs Specialist

4 days ago


Gurgaon, Haryana, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 22,50,000
Regulatory Affairs Specialist

About the Role:

We are seeking a skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring that our products comply with relevant regulations and guidelines.

Key Responsibilities:

  • Support the product lifecycle through obsolescence by assessing changes made to the device post-launch to determine regulatory impact of changes to the current clearance.
  • Evaluate regulatory history/background of class, disease/therapeutic/diagnostic context in the assessment of regulatory implications.
  • Determine and communicate submission and approval requirements.
  • Collaborate with cross-functional teams to develop and implement regulatory strategies.
  • Develop and maintain knowledge of regulatory requirements, legislation, processes, and procedures.

Requirements:

  • Bachelor's or Master's degree in Regulatory Affairs, Engineering, or equivalent discipline.
  • 3-5 years of experience in an equivalent position within an R&D environment.
  • Experience with post-market and change management is a distinct advantage.
  • RAC Certification is preferred.

About Us:

We are a global leader in medical technologies, driven to make healthcare better. Our innovative products and services help improve patient and healthcare outcomes. We impact more than 150 million patients annually.



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