Regulatory Affairs Specialist
2 weken geleden
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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