Senior Specialist, Commercial Regulatory Affairs

Danaher

New Delhi, India
**
Import license applications
Post approval change applications
Country specific regulations and guidelines
** Danaher is seeking a Senior Specialist in Commercial Regulatory Affairs for its Beckman Coulter Diagnostics division in New Delhi, India. The role involves managing import license applications and ensuring compliance with regulations specific to India and neighboring countries, requiring significant experience in medical device registration and strong analytical skills. **

Job Summary

  • The Sr. Specialist, Commercial Regulatory Affairs is responsible for preparation, submission and approvals for the Import license applications, renewals, and Post Approval change applications.
  • This position reports to the Manager, Commercial Regulatory Affairs (SWA) and is part of the Commercial Regulatory Affairs Center of Excellence (COE) located in New Delhi, India.
  • You’ll thrive in a culture of belonging where you and your unique viewpoint matter.

Matching Summary

Match Score: 75

** Danaher is seeking a Senior Specialist in Commercial Regulatory Affairs for its Beckman Coulter Diagnostics division in New Delhi, India. The role involves managing import license applications and ensuring compliance with regulations specific to India and neighboring countries, requiring significant experience in medical device registration and strong analytical skills. **

Skills & Requirements

Must-have

  • Import license applications
  • Post Approval change applications
  • Country specific regulations and guidelines
  • Respond to regulatory authority queries
  • Proactive regulatory intelligence

Nice-to-have

  • Continuous improvement culture
  • Collaborate with cross-functional departments
  • Harnessing Danaher's system

Key Requirements

  • Degree in Science / Pharmacy or related field
  • 8-10 years experience in medical devices or IVD industry
  • Well-versed understanding of Indian Medical Device Regulations 2017
  • Experience in matrix organization and international environment
  • Experience in managing people
  • Experience handling projects independently

Work Rights

Not specified

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