Senior Specialist, Commercial Regulatory Affairs

Danaher

New Delhi, India
**
8-10 years medical device registration experience
Indi medical device regulations 2017 knowledge
Import license application preparation and submission
** Danaher is seeking a Senior Specialist in Commercial Regulatory Affairs for Beckman Coulter Diagnostics in New Delhi, India. The role involves managing regulatory submissions and ensuring compliance with local regulations, particularly for medical devices and in-vitro diagnostics. **

Job Summary

  • The role focuses on preparing and submitting import license applications, renewals, and post-approval change filings for India, Sri Lanka, and other SWA countries.
  • Candidates will collaborate with cross-functional departments to manage in-country testing data requirements and provide regulatory assessments for product changes.
  • This position offers the opportunity to join a global leader in clinical diagnostics committed to saving lives through continuous innovation.

Matching Summary

Match Score: 75

** Danaher is seeking a Senior Specialist in Commercial Regulatory Affairs for Beckman Coulter Diagnostics in New Delhi, India. The role involves managing regulatory submissions and ensuring compliance with local regulations, particularly for medical devices and in-vitro diagnostics. **

Skills & Requirements

Must-have

  • 8-10 years medical device registration experience
  • Indi Medical Device Regulations 2017 knowledge
  • Import license application preparation and submission

Nice-to-have

  • Experience in matrix organization environment
  • Strong diplomatic negotiation skills
  • Ability to work independently on projects

Key Requirements

  • Degree in Science or Pharmacy
  • 8-10 years relevant registration experience
  • Well versed understanding of Indian Medical Device Regulations

Work Rights

Not specified

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