QA/RA specialist

Fysiologic

Amsterdam

On-site

EUR 65,000 - 90,000

Full time

14 days+

Get more replies from employers

Send a job-specific resume in minutes.

Job summary

Fysiologic, a MedTech leader in cardiac diagnostics, is seeking a QA/RA Specialist (32–40 hours) to join our Amsterdam team. You will ensure product quality and regulatory compliance across international markets, supporting registrations, audits, and continuous improvement.

You will collaborate with cross-functional teams to implement ISO 13485 and keep up with EU MDR/IVDR, FDA guidelines where applicable, and maintain robust quality systems.

Qualifications

Bachelor's or Master's degree in a technical, biomedical, or related field.
At least 2 years of experience in QA/RA or a related role.
Excellent command of Dutch and English, written and spoken.
Knowledge of international medical device regulations (ISO 13485, EU MDR/IVDR; FDA 21 CFR Part 820).
Strong communication, organizational, and project management skills.

Responsibilities

Monitor international regulatory requirements and advise internal teams on implications for product development and compliance.
Stay informed about regulatory changes and advise stakeholders on laws, regulations, and guidelines.
Manage product registrations and submissions to ensure timely approvals and market launches.
Implement, maintain, and continuously improve the quality management system in line with ISO 13485 and applicable regulations.
Serve as primary contact for regulatory agencies and notified bodies.
Handle product complaints and coordinate investigations, CAPA, and reporting activities.
Design and lead strategic quality improvement initiatives and transformation programs.
Monitor and report quality KPIs monthly to support continuous improvement.

Skills

Regulatory affairs knowledge

Quality assurance

Project management

Communication skills

Education

Bachelor's or Master's in technical/biomedical or related field

Tools

ISO 13485

EU MDR 2017/745

EU IVDR 2017/746

FDA 21 CFR Part 820

Job description

1 day ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

FYSIOLOGIC IS LOOKING FOR A QA/RA SPECIALIST (32–40 HOURS)

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 info@fysiologic.nl

Join Fysiologic, where innovation and care come together.

Seniority level