Responsibilities:

• Build and maintain certified MDR Quality Management System
• • Lead product registration process with Notified Body
• • Represent the QMS as deputy PRRC
• • Maintain local training compliance
• • Lead and participate in internal audits
• • Provide Quality related trainings
• • Organize site Management Review
• • Track and report KPIs
• • Supplier qualification including leading of audits
• • Site QARA projects

Skills Required:

• Bachelor’s degree in Life Science or equivalent
• • Minimum of 5 years’ experience in Regulatory Affairs, Clinical Affairs or Quality Assurance
• • Record of success and broad understanding of contemporary quality practices as they apply to product development,
• manufacturing, and commercial operations
• • Proven expertise in the design and implementation of quality processes in world-class medical device manufacturing
• organization under MDR regulation
• • Expertise in MDR, cGMP and other Regulatory compliance requirements
• • Experience in software development in the medical device context
• • Self-confidence and the ability to work with all levels of organization
• • Operates in a way that never compromises ethics and integrity
• • Advanced leadership skills
• • Ability to understand and adapt to different cultures and market needs
• • (Inter-)national travel as required by business (up to 10%)