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Specialist- Commercial Regulatory Affairs

Danaher

Beckman Coulter Life Sciences seeks a Commercial Regulatory Affairs Specialist to manage import licenses, renewals, and post-approval applications for medical devices and IVDs across India, Sri Lanka, and South Asia. The role involves regulatory submissions, authority correspondence, cross-functional collaboration, and guidance on labeling and manufacturing changes.

Responsibilities

  • Prepare and submit import license applications, renewals, and post-approval change filings
  • Coordinate with Business Unit Regulatory Affairs teams to gather required documentation
  • Respond timely to regulatory authority queries and manage project timelines
  • Collaborate with cross-functional teams on in-country testing and product registration needs
  • Provide regulatory guidance on labeling, promotional materials, and manufacturing or packaging changes

Requirements

  • Bachelor's degree in Science, Pharmacy, or related field
  • 7–8 years of experience in medical device or IVD registration processes
  • Deep knowledge of India Medical Device Regulations 2017 and amendments
  • Demonstrated analytical, problem-solving, and negotiation skills
  • Experience in matrix organizations and international regulatory environments
  • Proficiency in MS Office and IT systems; self-directed project management
Vacancy posted 4 days ago
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