
Regulatory Affairs Manager
5 days ago
Aurevia Oy is a leading expert organization in quality and regulatory affairs within the Nordic region. We are seeking an experienced medical device quality and regulatory expert to join our team.
The successful candidate will be responsible for:
- Building, maintaining, and developing the Quality Management System
- Planning, creating, updating, and providing guidance on regulatory compliance and technical documentation
- Conducting gap analyses of technical documentation, planning and reporting for biological evaluation, usability engineering, electrical safety documentation, software lifecycle management processes, clinical/performance evaluation, and registrations
- Performing audits and providing training
- External roles in client's quality and regulatory functions
To succeed in this role, you will need:
- Strong expertise (4+ years) in the medical device industry
- Experience in quality & regulatory affairs (e.g. ISO 13485, ISO 14971, MDR, IVDR)
- Specific experience in software and IEC 62304 or in vitro diagnostics (IVD) products is an advantage
- Experience in US FDA regulations is an advantage
- University or higher education degree (MSc. or PhD.)
- Excellent project management and communication skills
- A proactive, service-oriented mindset
- Ability to manage multiple projects simultaneously and work independently
- Fluent proficiency in English (spoken and written), additionally Finnish proficiency is preferred
We offer a dynamic and supportive work environment, with opportunities for growth and development. Our benefits package includes flexible working hours, comprehensive health insurance, and a phone benefit.
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