Medical Device Compliance Expert
6 days ago
We are looking for an experienced medical device quality and regulatory expert to join our team in a permanent, full-time position. As a member of our team, you will have the opportunity to provide high-quality services in quality and regulatory affairs, supporting both quality and regulatory needs throughout the entire lifecycle of medical devices and quality management systems.
Our team comprises nearly 200 skilled professionals in offices in Finland, Sweden, Poland, and Germany. We serve over 8000 customers in more than 60 countries worldwide. Our extensive experience and expertise ensure a strong local support network and a platform for discussions in an ever-changing and developing operating environment.
Your key responsibilities and tasks include:
- Developing and implementing effective quality management systems
- Providing guidance on regulatory compliance and technical documentation
- Conducting gap analyses of technical documentation, planning and reporting for various aspects of medical devices and quality management systems
- Performing audits and providing training to ensure compliance with relevant regulations
We require:
- 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
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