Medical Technical Safety Coordinator for the IT/MT Department
Workplace: Luleå, Sverige
Expires: June 1, 2025
At Region Norrbotten's IT/MT department, we work long-term with digital solutions and new technology. We have close cooperation with other departments throughout the organization, together working towards our common mission – to enable development for creating the best future health and care. Do you want to be part of the development of our work with medical technology at a strategic level? Then we have an exciting position for you here at Region Norrbotten!
Main requirements:
- Relevant higher education such as biomedical engineering, law, or equivalent
- Several years of experience in quality assurance or management systems
- Practical experience in risk management
- Good knowledge of applicable standards including ISO 9001, ISO 13485, ISO 14971, and ISO 62366
- Experience coordinating and conducting training sessions
- Experience driving strategic-level change management
- Ability to communicate development work clearly and engagingly to the organization
Responsibilities:
- Develop strategic work within medical technical safety
- Promote development and maintenance of various management systems
- Responsible for the management system within the medical technology area
- Train and support operations on quality assurance and risk management related to medical technology
- Serve as expert support during procurement of medical technical products to ensure compliance with quality and regulatory requirements
Required hard skills:
- Quality assurance
- Management systems
- Risk management
- Knowledge of ISO standards (ISO 9001, ISO 13485, ISO 14971, ISO 62366)
- Training coordination and delivery
- Change management
Recommended hard skills:
- Knowledge and experience with medical device regulations including MDR
- Experience with qualified investigative work within government agencies
- Experience working as a coordinator
- Experience in public sector and documentation of medical technical software
- In-depth knowledge of relevant medical technical regulations
Soft skills:
- Flexibility
- Ability to handle various assignments and work environments
- Structured work approach
- Prioritization and responsibility
- Planning to set goals and meet deadlines
- Clear communication adapted to audience and situation
- Considerate decision making
- Long-term perspective aligned with operational priorities
Natural languages:
- Swedish (Expert)
Cultural skills:
- Knowledge of Sweden's national minority languages (such as Sami, Meänkieli, Finnish, Romani Chib, Yiddish) is valued
- Active promotion of gender balance and diversity
- Works to ensure accessibility for all employees
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