Regulatory & Quality Consultant - SaMD

Company Description

Rellia Health offers regulatory and quality consulting for early-stage startups. We work with medical device and SaMD companies at pivotal moments: their first 510(k), their first QMS, their first Health Canada licensing decision, the question of whether their software is a device at all. The clients who come to us are often navigating these questions for the first time, and they're trusting us to guide them through it.

Role Description

This is virtual, project-based, independent contractor work. There is no minimum hourly commitment and you'll have complete flexibility in your working hours and hourly rate. In this position, you will guide clients on regulatory compliance and quality management systems specific to Software as a Medical Device (SaMD). Duties include developing quality management systems, conducting mock audits, analyzing regulatory requirements, advising strategies for compliance, and ensuring produ...