Compliance Manager
(MDR & PRRC)
Do you want to make a difference in digital healthcare and prevention?
Are you eager to be part of a fast-growing, data-driven health-tech startup with ambitious and passionate teammates?
Do you have in-depth knowledge of the laws and regulations we need to comply with as a healthcare provider, and are you looking for the next challenge in your career? Then this job at Clear.bio is perfect for you!
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.
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.
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.
Your Profile
To meet the PRRC requirements under MDR Article 15, you need:
Either:
A formal education in law, medicine, pharmacy, engineering, or another relevant scientific field plus at least one year of experience in regulatory affairs or quality management in the medical device industry.
Or:
At least four years of professional experience in regulatory affairs or quality management in the medical device industry.
→ Don’t fully meet these requirements yet? If you have a bachelor’s or master’s degree in law, engineering, life sciences, quality management, or a related field, plus at least 3 years of experience in quality management and/or regulatory affairs in the medical device or digital health industry, we’d still love to hear from you!
What You bring
Strong knowledge of ISO 13485, MDR (EU 2017/745), and ISO 14971.
Experience with medical device software (MDSW) and familiarity with IEC 62304, ISO 27001, Dutch healthcare regulations, GDPR, and the AI Act is a plus.
Proven experience with internal audits, CAPA, post-market surveillance (PMS), and continuous improvement processes.
In-depth knowledge of MDR (EU 2017/745), including vigilance and regulatory reporting requirements.
Experience working with Notified Bodies and regulatory authorities is a plus.
Strong analytical and problem-solving skills with great attention to detail.
Excellent communication and stakeholder management skills.
A data-driven, decisive, solution-oriented, and independent way of working.
A curious, driven, and process-oriented mindset with a pragmatic and hands-on approach.
Fluent in English (professional level); Dutch is a plus but not required.
Passionate about data, proactive, and a self-starter.
Not a 100% match but still think you’re the right fit? Tell us why!
Our Offer
Base salary with an attractive stock option plan.
High level of responsibility and autonomy in a fast-paced, informal, and hybrid work environment.
10 amazing teammates (and growing fast!). A fun and easily accessible office in Amsterdam—with potential for more locations soon.
The chance to make a real impact in the world of digital healthcare and prevention.
At Clear.bio, we work hybrid, with Tuesdays and Thursdays as preferred office days.
Working at a startup requires resilience and cross-functional collaboration. You’ll have the opportunity to contribute across different areas, and our can-do mentality fosters an entrepreneurial atmosphere.
We’d love to hear from you! Apply through the button below.
Got questions? Feel free to email Godelieve van Eekelen (godelieve@clear.bio)