Quality Expert with IVD Regulatory Focus
2 days ago
The role of a Quality Specialist with expertise in In-Vitro Diagnostics Regulations (IVDR) is crucial in driving the direction for quality standards in diagnostics at Novo Nordisk A/S. As a key member of the RDQ Operational Excellence department, you will be responsible for ensuring compliance with IVD regulations and other relevant requirements.
This position requires a strategic mindset, high degree of independence, and expertise in Quality Management Systems. You will act as a Quality Partner for key projects involving IVD solutions, collaborating with cross-functional teams and participating in strategic, cross-organizational projects.
Main Responsibilities:
- Ensure compliance with IVD regulations and other relevant requirements.
- Act as a Quality Partner and support key projects with IVD solutions.
- Collaborate with cross-functional teams and participate in strategic, cross-organizational projects.
- Expand organizational knowledge within the IVD medical device area.
- Provide QA support across Research & Development, including Quality Risk Management, Change Control, and Deviations.
Requirements:
- You hold a Master of Science degree within natural sciences (e.g., Pharmacy, Chemistry, Biology) with 6–8 years of experience in quality assurance, regulatory, or clinical affairs.
- You have strong knowledge of regulatory requirements for IVD, including IVD regulations and relevant ISO standards, and their application to pharmaceutical IVD medical devices.
- You are experienced in maintaining a Quality Management System, participating in supplier qualifications, audits and inspections, and fluent in written and spoken English.
- You are familiar with project management and possess a 'can do' mindset to explore innovative ideas and new ways of working.
- You have a proven ability to set direction, propose compliant solutions aligned with business needs, and identify opportunities with a structured approach.
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