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Lead Systems Engineer - Registration Documentation (Healthcare/medical devices)

Danaher
Bengaluru, IND
Full-time
Senior · 10+ years experience
Onsite
Discovered 3 weeks ago
Free

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In this role, you will have the opportunity to

Act as the primary point of contact between International Registrations and R&D for technical documentation required to support global product registrations.

Maintain, organize, and continuously improve the documentation library required for international registration activities.

Identify, collect, review, and provide technical documentation for registrations, renewals, and regulatory submissions worldwide.

Collaborate with Regulatory Affairs, International Registrations, Systems Engineering, and Product Development to ensure documentation is complete, accurate, and up to date.

Act as the R&D point of contact for Unique Device Identification (UDI) data and documentation, support retrieval of information from product documentation, and improve documentation processes while protecting confidential information and intellectual property.

The essential requirements of the job include

  • Bachelor’s degree in Engineering, Life Sciences, or a related scientific discipline.
  • 10+ years of experience in medical device development, Regulatory Affairs, Quality Assurance, Technical Documentation, or a related function within a regulated environment.
  • Demonstrated understanding of medical device regulatory requirements, including MDR, IVDR, FDA, or comparable international regulatory frameworks.
  • Experience working with medical device design documentation, including requirements, risk management, verification and validation, and product lifecycle documentation.
  • Experience managing controlled documentation systems and efficiently reviewing, interpreting, and retrieving information from complex technical documentation sets.

It would be a plus if you also possess previous experience in

Supporting international registrations for IVD or medical device products.

Working in cross-functional collaborations between R&D and Regulatory Affairs.

Building and managing SharePoint-based information management solutions.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com .

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