About Clear.bio

Clear.bio is a health-tech startup (2019) based in Amsterdam, and one of Europe’s hottest startups. Our ambition is to become one of Europe’s leading companies in digital therapeutics.

Our mission is to help millions of people with type 2 diabetes become the best and healthiest version of themselves, using data instead of pills, powered by cutting-edge technology and the latest nutritional science.

Clear.bio has developed a digital self-help tool that enables type 2 diabetes patients to discover their best diet, adopt a healthier lifestyle, and reduce their diabetes symptoms. Real-time bio-data, a smart app, and support from dietitians via chat provide personalized nutritional advice and behavioral coaching.

About the Role
Clear.bio is a frontrunner in digital healthcare innovation, developing advanced medical device software (MDSW) that enhances patient care and clinical outcomes. We are looking for a Compliance Manager (QM & PRRC) to manage our ISO 13485-certified quality management system (QMS), ensure MDR compliance, and uphold the highest quality standards for our digital medical devices.

Your Responsibilities

As our Compliance & Quality Manager, you will play a key role in maintaining and improving our QMS while ensuring compliance with MDR and other regulatory requirements for medical device software. You will collaborate closely with multidisciplinary teams to integrate quality principles throughout the product development process.

Your Daily Tasks

As our Compliance & Quality Manager, you’ll be at the heart of keeping our quality and compliance standards high. Here’s what you’ll be working on:

• Manage and continuously improve our ISO 13485-certified quality management system (QMS).

• Ensure we meet the MDR (EU 2017/745) and other relevant regulations for medical device software.

• Lead regulatory submissions, audits, and interactions with Notified Bodies and regulatory authorities.

• Strengthen risk management processes (ISO 14971) to guarantee product safety and compliance.

• Oversee software validation and ensure alignment with IEC 62304 and other industry standards.

• Be the go-to regulatory expert and point of contact for authorities regarding product compliance.

• Develop, implement, and maintain processes that keep us in line with national and international regulations (e.g., CE marking, FDA, ISO standards).

• Keep all regulatory documentation and submissions accurate and up to date.

• Work closely with our teams across R&D, product management, marketing, and legal to ensure compliance is embedded from design to distribution.

• Stay on top of regulatory changes and advise senior management on necessary updates.

• Manage post-market surveillance (PMS) and vigilance activities.

• Identify compliance risks and drive corrective and preventive actions (CAPA).

• Train and support internal teams on compliance, quality management, and risk assessment.

Optionally, you could take on legal responsibilities, such as reviewing and drafting legal contracts, like NDAs and other agreements.