Regulatory Affairs and Quality Assurance Specialist

1 week geleden

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

EU Regulatory Affairs and Quality Assurance Specialist

We are seeking an experienced EU Regulatory Affairs and Quality Assurance specialist to join our team at Canon Medical Systems Europe.

This role involves ensuring regulatory and quality compliance of medical devices according to applicable laws, regulations, standards, and guidance in the EU countries, UK, and Switzerland. As a key member of our cross-functional team, you will support the development and launch of new products, as well as maintain and improve existing systems and procedures.

Key Responsibilities

  • Develop, implement, and maintain quality systems in compliance with ISO 13485, ISO 9001, ISO 14001, and ISO 27001 requirements;
  • Evaluate and ensure regulatory compliance in the EU countries, UK, and Switzerland;
  • Implement EU MDR 2017/745 and MDCG requirements and support EUDAMED registrations, stay up-to-date on regulatory and quality system requirements, and provide guidance and training to cross-functional teams;
  • Ensure 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;
  • Identify root causes and implement corrective actions;
  • Participate in supplier audits and follow Supplier Corrective Action Requests;
  • Support internal audits and participate in CAPA and non-conformance processes.

Requirements

  • Bachelor's degree in a relevant field (life 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 We Offer

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

  • a gross monthly salary €6,000 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.

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