Raj Kumar P

Experience

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  HCL Technologies

  Dec 2021 - Apr 2024

  Roles and Responsibilities:Design and develop software solutions to ensure adherence to medical device regulations (FDA, MDR and ISO 13485).Develop controls and features to address compliance concerns.Conduct risk assessments and develop controls to mitigate compliance risks.Develop software systems for regulatory data management and documentation.Ensure software integration with existing systems and workflows.Analyze regulatory data for compliance efforts.Build and maintain systems for accurate and timely regulatory reporting.Perform software validation and verification to ensure compliance with standards.Conduct various levels of testing to ensure software performance meets regulatory compliance requirements.Foster cross-functional collaboration with regulatory affairs, quality assurance, and IT teams.Stay updated with the latest regulatory guidelines and implement improvements to software systems.Offer training and support to team members and stakeholders on software tools and regulatory compliance.Maintain comprehensive technical documentation and up-to-date records.Troubleshoot and resolve issues related to software performance, data integrity, and regulatory compliance. Show less Collecting and organizing regulatory data from internal databases and external reports.Supporting data entry tasks and ensuring data accuracy and completeness.Analyzing regulatory data to identify trends, patterns, and anomalies.Generating reports and visualizations for compliance and decision-making.Aiding in preparing regulatory documentation for submissions and compliance.Assisting in reviewing and proofreading regulatory documents.Conducting research on regulatory requirements and industry standards.Monitoring and tracking compliance-related activities.Working closely with regulatory affairs, quality assurance, and data management teams.Attending meetings and contributing to discussions on regulatory and data analysis projects.Participating in training sessions and workshops related to medical regulatory affairs and data analysis.Developing skills in data analysis tools, regulatory documentation, and compliance processes.Assisting with administrative tasks like scheduling meetings and maintaining records.Identifying and addressing issues related to data accuracy, regulatory compliance, and documentation. Show less

  • Software Engineer

    Jun 2022 - Apr 2024

  • Internship Trainee

    Dec 2021 - Jun 2022
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  Tata Elxsi

  Apr 2024 - now

  Engineer