Medical Devices Quality Specialist

Your Tasks:

• Participation in registration and certification procedures for the Company’s medical devices for the European and American markets
• Maintenance and development of the quality management system
• Participation in the creation and supervision of technical documentation of the product
• Conducting internal audits and participation in external audits dictated by the formal requirements of the regulatory authorities of the medical devices market
• Constant monitoring of regulations and requirements in the EU and the USA
• Supporting the regulatory manager in everyday activities, including conducting internal training
• Providing support for members of other teams in the regulatory area

What we expect from you:

• At least 2 years of professional experience in regulatory issues or quality management systems in the field of medical devices
• Higher education in the fields of medicine, biotechnology, medicinal chemistry, medical analytics, biomedical engineering
• Knowledge of standards and formal rules for regulating the medical devices market in the EU and the USA (MDR, ISO 13485, FDA)
• Knowledge of the English language, in speech and writing, to the extent that allows the preparation of documentation and formal applications to market regulatory authorities
• Independent problem solving and communication, meticulousness and the ability to work on many parallel projects

Nice to have:

• Formal qualifications of the ISO 13485 internal auditor
• Experience in risk analysis and management
• Experience in SaMD / MDSW projects (IEC 62304 standard) managed in accordance with agile methodology