Quality & Regulatory Affairs; QARA Associate

Position: Quality & Regulatory Affairs (QARA) Associate
Location: Bengaluru

Position:  Quality & Regulatory Affairs (QARA) Associate
Mode:  In-Office
Type:  Full time Opportunity
Status:  Immediate

Location:

Cureous, Bangalore

Job Introduction
Cureous  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 Overview
We 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 Responsibilities
QMS 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 & Qualifications

Education:

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 gain
Work with a high-growth Med Tech 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