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Regulatory Affairs and Quality Assurance Expert
1 maand geleden
Regulatory Affairs and Quality Assurance Expert
We 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 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.
Requirements:
- 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.
About Canon Medical Systems Europe
At Canon Medical Systems Europe, we offer a challenging environment with many opportunities to expand your knowledge and experience. In addition, 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.
