Junior Quality & Regulatory Engineer

You will be involved in writing and executing test and verification protocols for a portable spirometer. Collaborating with a regulatory consultant, you will help establish the ISO 13485 quality management system, while also maintaining key documentation including the design history file and risk management file.

Your role will have you working alongside the engineering team on design modifications and coordinating testing in the lab.

This role is open to candidates with a B.E./B.Tech in Electronics, Biomedical, or Computer Science, particularly from the 2025/2026 batches. Strong technical writing skills are essential, as the ability to clearly explain procedures on a single page is valued more than academic grades.

It helps to develop strong technical writing skills; being able to clearly document processes is crucial in this field. Familiarity with quality management systems like ISO 13485 can also be beneficial.

Gaining experience in testing protocols or regulatory documentation will strengthen your application. Additionally, try to familiarize yourself with the relevant standards such as ISO 14971 and IEC 62304.