Lead Systems Engineer - Registration Documentation

DHR Holding India; Bengaluru; On-site; INR 2,800,000 - 5,800,000; Full time

Job summary

DHR Holding India in Bengaluru on-site seeks a Lead Systems Engineer - Registration Documentation to coordinate and provide access to product technical documentation for global regulatory registrations. You will work with Regulatory Affairs, International Registrations, and R&D to ensure accuracy and completeness of documents.

The role requires extensive experience in medical device documentation, MDR/IVDR/FDA knowledge, and managing complex documentation sets, with a focus on protecting

Qualifications

• Bachelor's degree in engineering or life sciences.
• 10+ years in medical device development, regulatory affairs, QA, or technical documentation.
• Understanding MDR, IVDR, FDA and similar international frameworks.
• Experience with design documentation and product lifecycle documents.

Responsibilities

• Primary contact between International Registrations and R&D for technical documentation.
• Maintain and improve the documentation library for international registrations.
• Gather, review, and provide documentation for registrations, renewals, and regulatory submissions.
• Collaborate with Regulatory Affairs, International Registrations, Systems Engineering and Product Development.
• Act as R&D contact for UDI data and protect confidential information.

Skills

Regulatory affairs knowledge

Technical documentation management

Regulatory frameworks MDR/IVDR/FDA

Documentation retrieval and review

Education

Bachelor's degree in Engineering, Life Sciences, or related scientific discipline

Tools

SharePoint

Job description

Job Summary

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 Radiometers 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.

Responsibilities

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.

Essential Requirements

• 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.

Desirable Experience

• 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.

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