Regulatory Affairs and Quality Assurance Specialist
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.
- Maintain clear communication with internal and external stakeholders regarding the complaint handling outcomes.
- Ensure Field Safety Corrective Actions (FSCA) including the preparation of the Field Safety Notice (FSN) and reporting to Competent Authorities on time.
- Conduct internal audits to support compliance of complaint handling under the quality systems and regulatory requirements.
- Take a role to identify root causes and implement corrective actions.
- Ensure effective documentation review and implementation of the SOPs and Working Instructions
- Provide training to employees on updated procedures
What do you bring?
- Bachelor’s degree in a relevant field (i.e. engineering, 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.
- Must be living in the Netherlands, close by the office.
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 B.V.
Canon Medical Systems is a world leading healthcare provider. Our ‘Made for Life’ philosophy reflects our ongoing commitment to humanity. We provide medical professionals with solutions that support their efforts in contributing to the health and wellbeing of patients worldwide.
Made for life reflects our commitment to enhancing the quality of life for our people. We offer a coaching and development platform focused on well-being and resilience, ensuring everyone thrives both at work and beyond.
CANON Medical Systems Europe BV attaches great importance to diversity and inclusion and offers a respectful working environment in which there is no room for discrimination and intimidation. We endorse governmental policies for hiring and promoting individuals based on their merit, regardless of race, religion, sex, national origin, age, disability, pregnancy, marital status, sexual orientation, gender identity or -expression.