Regulatory Affairs Specialist

2 weken geleden


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

Regulatory Affairs and Quality Assurance Specialist

We 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 Switzerland.
  • Implement EU MDR 2017/745 and MDCG requirements, and support EUDAMED registrations.
  • 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-up on corrective action requests.

Requirements:

  • Bachelor's degree in a relevant field (e.g., science, quality management).
  • 3-5 years of experience in medical device quality assurance and regulatory affairs.
  • Strong understanding of regulatory requirements and quality systems.
  • Strong knowledge of ISO 13485 and ISO 9001.
  • Excellent English language skills, both written and spoken.
  • Excellent communication and interpersonal skills.
  • Strong analytical and problem-solving skills.
  • Excellent organizational and time management skills.

What We Offer:

  • 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.


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