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Position:Quality & Regulatory Affairs (QARA) Associate Mode:In-Office Type:Full time Opportunity Status:ImmediateLocation:Cureous, BangaloreJob Introduction Cureousis 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 Overview We are seeking a detail-oriented and proactiveQuality & Regulatory Affairs (QARA) Associateto 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 Responsibilities QMS Implementation:Assist in the end-to-end implementation of QMS as perISO 13485and21 CFR Part 820(FDA) requirements. CDSCO Submissions:Aid in the creation and management of regulatory documents and dossiers forCDSCOsubmissions to ensure market clearance. Cross-Functional Support:Work closely with the Engineering team to support the implementation ofDesign Controls(Design History Files) andRisk Management(ISO 14971). Lifecycle Management:Manage core QMS activities includingChange Control ,Non-Conformance Reports (NCRs) ,CAPAs(Corrective and Preventive Actions), andComplaint Handling . Standards Analysis:Deep-dive into and interpret technical standards such asIEC 62304(Software),IEC 60601(Safety), andIEC 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 & Qualifications Education:Bachelor’s or Master’s inBiomedical Engineeringor a related technical field. Regulatory Knowledge:Foundational understanding ofISO 13485 ,ISO 14971 , and theIndian 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 gain Work with a high-growth MedTech startup shaping the future of healthcare Gain exposure to startup finance, fundraising, and grant management Work closely with the leadership team and make a visible impact Be part of an award-winning, mission-driven team believing in making a difference