JOB PURPOSE
The Regulatory & Design Assurance Engineer (Fresh Graduate) supports
the development of NEXA wearable medical devices by ensuring that product
design, risk management, verification, and regulatory documentation align with
medical device standards and design control requirements.
The role focuses on regulatory readiness, design assurance, risk
management, verification & validation coordination, and product quality
throughout the product development lifecycle. Working closely with hardware,
embedded software, machine learning, software, clinical, and regulatory teams,
the engineer helps ensure that NEXA products are developed with clear
traceability, structured verification evidence, and compliance with
international medical device standards.
This role provides hands-on exposure to medical device development
practices including ISO 13485 design controls, ISO 14971 risk management,
verification & validation engineering, and regulatory documentation
frameworks, as well as broader regulatory lifecycle considerations such as
manufacturing readiness, labeling, and regulatory submissions.
Deadline
18 May 2026