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Are you passionate about Quality and Regulatory Affairs and working for an innovative MedTech company?
Fysiologic, a market leader in cardiac diagnostics, is looking for a meticulous and experienced professional with an eye for detail and a passion for quality and regulatory compliance.
As a Quality & Regulatory Specialist, you will play a key role in ensuring our product quality and compliance with national and international laws and regulations.
In this role, you’ll be essential in supporting our fast-growing organization by laying a solid foundation in quality and regulatory affairs. Fysiologic is part of ACE Health AB, a pioneer in cardiac care. ACE Health AB is a scale-up with international growth ambitions through acquisitions and partnerships on a global scale, meaning this role will also contribute to international acquisition processes.
Ready to take the next step in your career?
We’d love to hear from you!
ABOUT US
Fysiologic Smart ECG Solutions specializes in ECG diagnostics.
We began recording and analyzing ECGs in 1977 for general practitioners, specialists, and hospitals. That means we’ve now performed over two million analyses-a number that continues to grow exponentially.
Driven by our passion for ECGs, we continuously expand our knowledge and introduce new forms of diagnostics. Many of the products, both software and hardware, are developed and produced in-house.
REQUIREMENTS
A successful QA/RA Specialist should have:
- A completed bachelor’s or master’s degree (HBO/WO), preferably in a technical, biomedical, or related field.
- At least 2 years of experience in a similar role.
- Excellent command of Dutch and English, both spoken and written.
- Demonstrated knowledge of international medical device regulations, including ISO 13485, EU MDR (2017/745), EU IVDR ( 2017/746) and preferably FDA 21 CFR Part 820.
- Strong communication, organizational, and project management skills.
- A proactive, detail-oriented mindset and the ability to work collaboratively across departments.
WHAT WE OFFER
A competitive salary with plenty of opportunities for growth. You’ll work in a friendly, professional, and driven team.
YOUR RESPONSIBILITIES
This role involves a wide range of responsibilities, including:
- Monitor international regulatory requirements and advise internal teams on implications for product development and compliance.
- Staying informed about regulatory changes and advising internal stakeholders on laws, regulations, and guidelines.
- Manage product registrations and submissions to ensure timely approval and successful market launches.
- Implement, maintain, and continuously improve the quality management system in compliance with ISO 13485 and applicable regulations.
- Serve as the primary contact for regulatory agencies and notified bodies.
- Handling product complaints and maintaining overall responsibility for products within the quality management system.
- Acting as the point of contact for quality and compliance matters.
Handle product complaints and coordinate investigations, CAPA, and reporting activities. - Manage quality documentation, including change control processes and approval workflows.
- Design and lead strategic quality improvement initiatives and transformation programs in line with business goals.
- Monitor and report on quality KPIs monthly, using data to support continuous improvement initiatives.
ABOUT ACE HEALTH AB
Fysiologic is part of ACE Health AB, a global leader in cardiac diagnostic services.
As the market leader in the Netherlands, Fysiologic is known for its expertise and commitment to high-quality cardiac diagnostics.
With ACE Health AB’s ongoing growth, we are expanding our capabilities to deliver innovative, fully integrated solutions to healthcare providers worldwide.
Working at Fysiologic means joining a fast-growing company with international impact and a strong focus on healthcare advancement.
HOW TO APPLY
Are you passionate about regulatory affairs and healthcare, and want to contribute to a leading company in cardiac diagnostics.
We’d love to hear from you!
Click & Apply or send your CV and motivation letter to infofysiologic.nl .
Join Fysiologic, where innovation and care come together.
