Regulatory Affairs and Quality Assurance Specialist

3 maanden geleden

Zoetermeer, Nederland Canon Medical Systems Europe Voltijd

Regulatory Affairs and Quality Assurance Specialist

We are seeking a highly motivated and experienced Medical Device Regulatory Affairs and Quality Assurance specialist to join our team.

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?

Develop, implement and maintain quality systems in compliance with ISO 13485, ISO 9001, ISO 14001 and ISO 27001 requirements; Ensure regulatory compliance in the EU countries as well as UK and Switzerland; Implement EU MDR 2017/745 and MDCG requirements and support on EUDAMED registrations, stay up to date on regulatory and quality system requirements and provide guidance and training to cross-functional teams; Ensure that complaint handling processes are implemented and followed, and that complaint investigation reports are properly documented and closed in a timely manner; Conduct internal audits to support compliance with quality systems and regulatory requirements; Take a role to identify root causes and implement corrective actions; Participate in supplier audits and follow the Supplier Corrective Action Requests; Support internal audits and take a role in the CAPA and non-conformance processes.

What do you bring?

Bachelor’s degree in a relevant field (, 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; Excellent organizational and time management skills, with the ability to manage multiple projects and priorities;

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 appropriate to 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.

About Canon Medical Systems Europe

If you want to apply, please apply on LinkedIn at:

  • Regulatory Affairs and Quality Assurance Expert

    6 dagen geleden

    Zoetermeer, Zuid-Holland, Nederland Canon Medical Systems Europe Voltijd

    Regulatory Affairs and Quality Assurance ExpertWe are seeking a highly motivated and experienced Medical Device Regulatory Affairs and Quality Assurance specialist to support the development and launch of new products, as well as the ongoing maintenance and improvement of existing systems and procedures.Key Responsibilities:Develop, implement and maintain...

  • Regulatory Affairs and Quality Assurance Expert

    1 week geleden

    Zoetermeer, Zuid-Holland, Nederland Canon Medical Systems Europe Voltijd

    Regulatory Affairs and Quality Assurance ExpertWe are seeking a highly motivated and experienced Medical Device Regulatory Affairs and Quality Assurance specialist to support the development and launch of new products, as well as the ongoing maintenance and improvement of existing systems and procedures.Key Responsibilities:Develop, implement and maintain...

  • Regulatory Affairs Specialist

    1 maand geleden

    Zoetermeer, Zuid-Holland, Nederland Canon Medical Systems Europe Voltijd

    Job Title: Regulatory Affairs and Quality Assurance SpecialistWe are seeking a highly motivated and experienced Medical Device Regulatory Affairs and Quality Assurance specialist to join our team at Canon Medical Systems Europe.Key Responsibilities:Develop, implement, and maintain quality systems in compliance with ISO 13485, ISO 9001, ISO 14001, and ISO...

  • Regulatory Affairs Specialist

    4 weken geleden

    Zoetermeer, Zuid-Holland, Nederland Canon Medical Systems Europe Voltijd

    Regulatory Affairs and Quality Assurance SpecialistWe are seeking a highly motivated and experienced Medical Device Regulatory Affairs and Quality Assurance specialist to join our team at Canon Medical Systems Europe.Key Responsibilities:Develop, implement, and maintain quality systems in compliance with ISO 13485, ISO 9001, ISO 14001, and ISO 27001...

  • Regulatory Affairs Specialist

    3 weken geleden

    Zoetermeer, Zuid-Holland, Nederland Canon Medical Systems Europe Voltijd

    Job Title: Regulatory Affairs and Quality Assurance SpecialistWe are seeking a highly motivated and experienced Medical Device Regulatory Affairs and Quality Assurance specialist to join our team at Canon Medical Systems Europe.Key Responsibilities:Develop, implement, and maintain quality systems in compliance with ISO 13485, ISO 9001, ISO 14001, and ISO...

  • Regulatory Affairs Specialist

    4 weken geleden

    Zoetermeer, Zuid-Holland, Nederland Canon Medical Systems Europe Voltijd

    Regulatory Affairs and Quality Assurance SpecialistWe are seeking a highly motivated and experienced Medical Device Regulatory Affairs and Quality Assurance specialist to support the development and launch of new products, as well as the ongoing maintenance and improvement of existing systems and procedures.Key Responsibilities:Develop, implement, and...

  • Regulatory Affairs Specialist

    4 weken geleden

    Zoetermeer, Zuid-Holland, Nederland Canon Medical Systems Europe Voltijd

    Regulatory Affairs and Quality Assurance SpecialistWe are seeking a highly motivated and experienced Medical Device Regulatory Affairs and Quality Assurance specialist to support the development and launch of new products, as well as the ongoing maintenance and improvement of existing systems and procedures.Key Responsibilities:Develop, implement, and...

  • Regulatory Affairs Specialist

    2 weken geleden

    Zoetermeer, Zuid-Holland, Nederland Canon Medical Systems Europe Voltijd

    Regulatory Affairs and Quality Assurance SpecialistWe are seeking a highly motivated and experienced professional to join our team at Canon Medical Systems Europe.Key Responsibilities:Develop and implement quality systems in compliance with ISO 13485, ISO 9001, ISO 14001, and ISO 27001 requirements.Ensure regulatory compliance in the EU, UK, and...

  • Quality Assurance Specialist

    7 dagen geleden

    Zoetermeer, Zuid-Holland, Nederland Miniclip Voltijd

    Role OverviewAt Miniclip, we are seeking a skilled Quality Assurance Specialist to join our team. As a QA Specialist, you will play a crucial role in ensuring the smooth release of our new game, providing an optimal user experience for our players.Key ResponsibilitiesCollaborate with the development team to identify and resolve errors, inconsistencies, and...

  • Quality, Health, Safety

    1 maand geleden

    Zoetermeer, Zuid-Holland, Nederland DynaGroup Voltijd

    Job Title: Quality, Health, Safety & Environment SpecialistAt DynaGroup, we are committed to providing exceptional logistics services to our clients. As a Quality, Health, Safety & Environment Specialist, you will play a crucial role in ensuring that our operations meet the highest standards of quality, health, and safety.Key Responsibilities:Develop and...

  • Quality Assurance Specialist

    1 week geleden

    Zoetermeer, Zuid-Holland, Nederland Miniclip Voltijd

    What will you be doing at Miniclip?You and your team will be responsible for ensuring the smooth release of our new game, providing an optimal user experience for our players. As a Quality Assurance Engineer, you will take pride in identifying and resolving errors, inconsistencies, and crashes before they affect our users. Your clear reporting and...

  • Quality Assurance Systems Lead

    4 weken geleden

    Zoetermeer, Zuid-Holland, Nederland Danone Voltijd

    Introduction and Role Overview Quality Systems Manager At Danone, we are dedicated to producing specialized liquid medical nutrition that supports the health of vulnerable populations, including infants, the elderly, and those facing health challenges. Our operations extend to over 55 countries and are integral to our Specialized Nutrition Division,...

  • Manager of Quality Assurance Processes

    4 weken geleden

    Zoetermeer, Zuid-Holland, Nederland Danone Voltijd

    Overview of the Role Quality Systems Manager At Danone, we are dedicated to producing specialized liquid medical nutrition that supports the health of vulnerable populations across the globe. As part of our Specialized Nutrition Division, the Quality Systems Manager plays a crucial role in ensuring that our products meet the highest standards of...

  • Quality Management Systems Supervisor

    4 weken geleden

    Zoetermeer, Zuid-Holland, Nederland Danone Voltijd

    Overview of the Role Quality Systems Manager At Danone, we are dedicated to producing specialized liquid medical nutrition that supports the health of vulnerable populations across the globe. As part of our Specialized Nutrition Division, the Quality Systems Manager plays a crucial role in ensuring that our products meet the highest standards of...

  • Quality Systems Manager

    2 maanden geleden

    Zoetermeer, Zuid-Holland, Nederland Danone Voltijd

    About the JobQuality Systems ManagerDanone is seeking a highly skilled Quality Systems Manager to join our team in Zoetermeer. As a Quality Systems Manager, you will be responsible for developing, implementing, and maintaining robust food safety and quality management systems to ensure uncompromising food safety, specified quality, and regulatory...

  • Quality Assurance Specialist

    2 weken geleden

    Zoetermeer, Zuid-Holland, Nederland Miniclip Voltijd

    Join Miniclip as a QA TesterAt Miniclip, we're looking for a skilled QA Tester to join our team. As a QA Tester, you'll play a crucial role in ensuring the quality of our games and providing an optimal user experience for our players.Key Responsibilities:Identify and report bugs and issues in our gamesCollaborate with the development team to resolve issues...

  • Quality Systems Manager

    4 weken geleden

    Zoetermeer, Zuid-Holland, Nederland Danone Voltijd

    Quality Systems ManagerAt Danone, we are seeking a highly skilled Quality Systems Manager to join our team. As a key member of our Specialized Nutrition Division, you will be responsible for developing, implementing, and maintaining robust food safety and quality management systems to ensure uncompromising food safety and regulatory compliance.Main...

  • Quality Assurance Specialist

    1 maand geleden

    Zoetermeer, Zuid-Holland, Nederland Miniclip Voltijd

    About the RoleWe are seeking a skilled QA Engineer to join our team at Miniclip. As a QA Engineer, you will play a crucial role in ensuring the quality of our new game releases.Key ResponsibilitiesCollaborate with the development team to identify and report defectsDevelop and execute test plans to ensure high-quality releasesWork closely with the team to...

  • Quality Systems Manager

    1 maand geleden

    Zoetermeer, Zuid-Holland, Nederland Danone Voltijd

    Quality Systems ManagerAt Danone, we are seeking a highly skilled Quality Systems Manager to join our team in Zoetermeer. As a key member of our Specialized Nutrition Division, you will be responsible for developing, implementing, and maintaining robust food safety and quality management systems to ensure uncompromising food safety and regulatory...

  • Quality Systems Manager

    3 weken geleden

    Zoetermeer, Zuid-Holland, Nederland Danone Voltijd

    About the JobQuality Systems ManagerDanone is seeking a Quality Systems Manager to join our team in Zoetermeer. As a Quality Systems Manager, you will be responsible for developing, implementing, and maintaining robust, effective, and efficient food safety and quality management systems to ensure uncompromising food safety, specified quality, and regulatory...