Regulatory Affairs and Quality Assurance Specialist

Made for Patients. Made for Partnerships. Made for you.

For more than 100 years, Canon Medical has been at the cutting edge of diagnostic imaging, creating healthcare solutions that improve people’s lives. We partner with leading clinical and academic institutions around the world to develop systems and services that push the boundaries of image quality and workflow efficiency.

Inspired by our “Made for Life” philosophy, we are dedicated to providing healthcare solutions that address the real-world needs and concerns of patients, medical professionals, customers and partners. Working at Canon Medical Systems Europe you will get the opportunity to make a difference in people’s lives while working with us.

The role

In this role, you will be responsible for ensuring the regulatory and quality compliance of devices according to the applicable laws, regulations, standards, and guidance. You will be working closely with cross-functional teams to support the development and launch of new products, as well as the ongoing maintenance and improvement of existing systems and procedures.

What will you do?

• Act as product approver, verifying compliance of documentation (e.g. DoC, labelling) with EU MDR and related regulations (REACH, RoHS, WEEE, Battery Regulation, AI Act).
• Ensure regulatory compliance for medical devices across EU, UK and Switzerland.
• Manage and maintain supplier qualification and approval, including risk classification and performance monitoring.
• Lead and improve nonconformance (NC) and CAPA processes, including root cause analysis and corrective actions.
• Support implementation of EU MDR/MDCG requirements and EUDAMED registrations; provide guidance to stakeholders.
• Conduct internal audits and ensure compliance across products, suppliers and processes.
• Maintain and improve the Quality Management System in line with ISO standards (13485, 9001, 14001, 27001).
• Ensure proper documentation, SOP implementation and deliver training on procedures and compliance topics.

What do you bring?

• Bachelor’s degree in a relevant field (i.e. engineering, science, quality management).
• 3-5 years of experience in medical device quality assurance and regulatory affairs.
• Strong understanding of regulatory requirements and quality systems requirements.
• Strong knowledge about the ISO 13485 and ISO 9001.
• Experience with medical device technical file preparation.
• Excellent English language skills both written and spoken, ideally you also speak and understand an additional EU language.
• Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment.
• Strong analytical and problem-solving skills with the ability to identify root causes and implement corrective actions.

What do we offer?

You will work in a professional team and in a challenging environment with many opportunities to expand your knowledge and experience. In addition, we offer you:

• a gross monthly salary between €4.200 and €6.200 - aligned with your knowledge and work experience;
• a 13th month and 8% vacation allowance;
• 32 vacation days and 5 scheduled days off;
• travel expenses / home office allowance.

Do you want to apply or do you need more information?

Please apply on our LinkedIn via: Regulatory Affairs and Quality Assurance Specialist | Canon Medical Systems Europe | LinkedIn

For questions, you can contact Bart Spring in ’t Veld, Talent Acquisition Specialist, at bart.springintveld@eu.medical.canon. Due to GDPR reasons we cannot accept applications by email.