Quality and Regulatory Lead
1 week ago
In this role, you will be responsible for ensuring the quality and regulatory compliance of medical devices and quality management systems throughout their entire lifecycle. You will have the opportunity to collaborate with our skilled professionals, contributing to the development of high-quality services in quality and regulatory affairs.
The ideal candidate will have:
- 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
You will also have the opportunity to:
- Participate in the development of our services and contribute to the growth of our company
- Collaborate with our international teams in Finland, Sweden, Poland, and Germany
- Support our customers in meeting their quality and regulatory requirements
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