As Regulatory Affairs and Quality Assurance Specialist you are accountable for the effective implementation and continuous improvement of quality management system for Noona. You keep abreast of regulatory procedures and changes and you may interact with regulatory agencies on defined matters.
 
You work in close collaboration with other development teams and stakeholders in Europe and overseas.

Main Responsibility
 

• Ensure effective implementation and continuous improvement of quality management system in accordance with applicable government regulations and standards   Establishes and maintains the Quality Management System documentation
• Prepare annual internal and supplier audit schedules, maintains audit programs and conducts audits
• Assist with regulatory agency inspections and external audits
• Support the implementation of Corrective and Preventive Action process
• Represent the Quality Assurance function on the development team. Reviews and approves Product Life Cycle documents in the Quality Assurance role.
• Monitor and support implementation of the risk management throughout design and development projects
• Coach, train and motivate the engineering to apply the procedures in design and development of medical devices throughout the projects
• Perform analysis and identifies trends of quality data and recommends corrective actions when necessary
• Coordinate the efforts associated with the preparation of regulatory documents for international regulatory submissions
• Prepare and maintain technical files and certificates as necessary to obtain and sustain product approval
• Advise engineering project teams and manufacturing on regulatory and labeling requirements
• Extend and maintain the knowledge on existing and emerging international and local regulations, standards, or guidance documents
• Escort government inspectors during inspections and provide pre- and post-inspection follow-up information

• Master's degree in medical physics, engineering, or related technical field with comparable educational background
• 2-5 years of experience in standards and government regulations applicable to medical devices
• Experience of working and communicating with different regulatory authorities and corresponding relationships
• Fluence in English, written and verbal