Quality And Regulatory Affairs Specialist: Quality Management Systems

Job Title: Quality and Regulatory Affairs Specialist Quality Management Systems

Location: Bangalore / Hybrid

Department: Quality & Compliance

Reports to: Head Quality & Regulatory Affairs / Legal Counsel

About Ultrahuman

Ultrahuman is a health-tech company building the worlds most advanced metabolic fitness platform through connected wearable technology and science-backed insights. Our products including the Ultrahuman Ring, M1 CGM, and Blood Vision diagnostics — combine hardware, software, and physiology to help users optimise sleep, movement, and nutrition.

We are expanding our Quality and Regulatory Affairs (QARA) function to support the implementation of a Quality Management System (QMS) aligned with ISO 13485, EU MDR, and related global medical-device frameworks.

Role Summary

We are looking for a QA/RA professional who can take ownership of documentation, process alignment, and cross-functional collaboration needed to build and maintain Ultrahuman’s QMS. The role involves working closely with legal, manufacturing, R&D, and product teams to ensure that all processes, documentation, and compliance activities meet medical-device regulatory expectations.

This position suits someone who enjoys structure and precision, understands how QMS frameworks work, and can translate regulatory requirements into clear internal documentation and workflows.

Key Responsibilities

• Support and coordinate the implementation of Ultrahuman’s QMS for medical devices and medical-grade features.
• Develop, organise, and maintain controlled documentation, including SOPs, process maps, and records in accordance with ISO 13485.
• Collaborate with cross-functional teams to align design, development, and operational processes with quality requirements.
• Track and support activities related to risk management, verification, validation, and traceability documentation.
• Assist in internal audits, CAPA management, and process-improvement initiatives.
• Ensure accuracy, completeness, and timely updates of all QARA documentation and quality records.
• Contribute to team training and awareness on QMS processes and compliance standards.

Qualifications / Skills / Knowledge

• Prior experience in Quality Assurance / Regulatory Affairs within a medical-device or health-tech environment.
• Good understanding of ISO 13485, EU MDR, and basic QMS concepts.
• Strong documentation and organisational skills with attention to detail.
• Ability to interpret regulatory requirements and translate them into practical internal processes.
• Excellent communication skills and ability to work collaboratively with legal, R&D, product, and manufacturing teams.
• Self-driven, structured, and comfortable managing multiple tasks in a fast-moving environment.

Why Join Ultrahuman

You’ll help shape the foundation of Ultrahuman’s medical-device compliance systems — bridging innovation and regulation in one of the fastest-growing global health-tech companies. Your work will directly enable our transition towards a fully compliant, ISO 13485-certified ecosystem that powers the future of human performance and health intelligence.

What Ultrahuman Offers

• Opportunity to build a QMS from the ground up in a fast-growing global health-tech company.
• Collaboration with world-class engineers, designers, and scientists.
• A culture that values scientific precision, regulatory discipline, and innovation.
• Competitive compensation, benefits, and a mission-driven environment transforming human health.