Origin Medical Research Lab is a cutting-edge research hub affiliated with Origin Medical, a Cambridge, Massachusetts-based company dedicated to advancing maternal health equity. Specializing in the integration of artificial intelligence (AI) and healthcare, the lab develops state-of-the-art solutions to improve prenatal care globally. With a mission to enhance pregnancy outcomes, reduce maternal and infant mortality rates, and democratize access to quality prenatal care, Origin Medical Research Lab fosters an environment of innovation, collaboration, and purpose-driven work.
Located in Bengaluru, Karnataka, Origin Medical Research Lab combines global expertise with local insight to design impactful medical products, adhering to stringent regulatory and quality standards such as ISO 13485:2016.
Responsibilities in the Job
As a Regulatory Affairs and Clinical Research Analyst Intern, you will play a pivotal role in ensuring regulatory compliance and driving impactful clinical research. Key responsibilities include:
Regulatory Responsibilities
- Regulatory Compliance: Ensure compliance with global and local regulatory guidelines, including U.S. FDA directives.
- Document Management: Maintain and update quality assurance and regulatory documents, including the Master Document List.
- Change Management: Manage document changes, approvals, and records per ISO standards.
- Monitoring Updates: Stay updated on changes in medical regulations and adapt documentation accordingly.
Clinical Research Responsibilities
- Clinical Trial Design: Plan, execute, and manage clinical studies in collaboration with investigators and Contract Research Organizations (CROs).
- Site Management: Develop strategies for site selection, staff training, and ongoing trial monitoring.
- Data Analysis: Coordinate with research teams for clinical data benchmarking and statistical assessments.
- Documentation: Prepare technical reports, ethics board applications, and compliance documentation.
Cross-Functional Responsibilities
- Safety and Efficacy: Collaborate with clinicians and engineers to ensure the safety and effectiveness of medical devices.
- Quality Management: Transition to electronic Quality Management Systems (e-QMS) for streamlined document control and compliance.
Qualifications
To excel in this role, candidates should possess:
- Educational Background: A strong understanding of healthcare products, AI technology, and medical devices.
- Attention to Detail: High degree of accuracy in repetitive tasks and documentation.
- Regulatory Knowledge: Familiarity with SaMD (Software as a Medical Device) and FDA regulations is advantageous.
- Communication Skills: Proficiency in written and verbal communication for technical documentation.
