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Position: Quality & Regulatory Affairs (QARA) AssociateMode: In-OfficeType: Full time OpportunityStatus: ImmediateLocation: Cureous, BangaloreJob IntroductionCureous is a medical technology spinoff from AIIMS New Delhi pioneering India’s first intelligent patient repositioning system, Eturnal™. We are an award winning company recognised and funded by institutions including Bill & Melinda Gates Foundation. Our mission is to transform patient care and reduce the burden on healthcare workers through innovative, human-centered technologies.Role OverviewWe are seeking a detail-oriented and proactive Quality & Regulatory Affairs (QARA) Associate to support the implementation and maintenance of our Quality Management System (QMS) and regulatory compliance for medical devices. You will work closely with engineering, manufacturing, and leadership teams to ensure our products meet applicable standards and regulatory requirements across their lifecycle.Key ResponsibilitiesQMS Implementation: Assist in the end-to-end implementation of QMS as per ISO 13485 and 21 CFR Part 820 (FDA) requirements.CDSCO Submissions: Aid in the creation and management of regulatory documents and dossiers for CDSCO submissions to ensure market clearance.Cross-Functional Support: Work closely with the Engineering team to support the implementation of Design Controls (Design History Files) and Risk Management (ISO 14971).Lifecycle Management: Manage core QMS activities including Change Control, Non-Conformance Reports (NCRs), CAPAs (Corrective and Preventive Actions), and Complaint Handling.Standards Analysis: Deep-dive into and interpret technical standards such as IEC 62304 (Software), IEC 60601 (Safety), and IEC 62366 (Usability) to identify design inputs.Internal Training: Conduct training for the team on QMS processes to ensure a culture of /"Good Documentation Practices/" (GDP).Skills & QualificationsEducation: Bachelor’s or Master’s in Biomedical Engineering or a related technical field.Regulatory Knowledge: Foundational understanding of ISO 13485, ISO 14971, and the Indian Medical Device Rules 2017.Execution Mindset: A proactive, /"insane focus/" to get things done fast. You don't wait for instructions; you find the standard and propose the solution.Analytical Writing: Strong ability to interpret complex regulations and translate them into clear, concise technical documentation.Communication: Ability to effectively interact with engineering, manufacturing, and external stakeholders.What you’ll gainWork with a high-growth MedTech startup shaping the future of healthcareGain exposure to startup finance, fundraising, and grant managementWork closely with the leadership team and make a visible impactBe part of an award-winning, mission-driven team believing in making a difference