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

Radiometer; Bengaluru; On-site; INR 5,500,000 - 7,500,000; Full time

Job summary

Radiometer, a Danaher company based in Bengaluru, seeks a Lead Systems Engineer - Registration Documentation to coordinate global regulatory registrations and maintain a comprehensive technical documentation library for Radiometer's portfolio.

You will work with Regulatory Affairs, International Registrations, and R&D to ensure documentation is complete, accurate, and in line with MDR/IVDR/FDA requirements, while protecting sensitive information.

Qualifications

• 10+ years of experience in medical device development, regulatory affairs, quality assurance, or technical documentation within a regulated environment.
• Demonstrated understanding of medical device regulatory requirements (MDR, IVDR, FDA or international frameworks).
• Experience with design documentation including requirements, risk management, verification/validation, and lifecycle documentation.

Responsibilities

• Act as primary contact between International Registrations and R&D for technical documentation to support global product registrations.
• Maintain and improve the documentation library for international registration activities.
• Identify, collect, review, and provide documentation for registrations, renewals, and regulatory submissions.
• Collaborate with Regulatory Affairs, International Registrations, Systems Engineering, and Product Development to ensure documentation is complete and up to date.
• Act as R&D contact for UDI data and documentation and protect confidential information.

Skills

Regulatory affairs

Technical documentation

Document control

Education

Bachelor's degree in Engineering or Life Sciences

Tools

SharePoint

Job description

Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?
At Radiometer, one of Danaher's 15+ operating companies, our work saves lives- and we're all united by a shared commitment to innovate for tangible impact.
You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.
At Radiometer, life comes first. Our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses. We're a team that celebrates diverse ideas and continuous improvement. Here, you'll find a place to grow and make a real impact, with your unique perspective driving us forward in improving patient care. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.
Learn about the Danaher Business System which makes everything possible.
The Lead Systems Engineer - Registration Documentation serves as the primary R&D interface to the International Registrations organization and is responsible for coordinating, retrieving, interpreting, maintaining, and providing efficient access to product technical documentation required to support global regulatory registrations, renewals, and market access activities across Radiometer's product portfolio. This position reports to the Engineering Manager and is part of the R&D Systems Engineering - PLM department located in Bengaluru and will be an on-site role.

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.