QARA Associate

QARA Associate or Quality and Regulatory Affairs Associate required to help register products in different markets in accordance with the local legal requirements. They are also the maincontact between the organisation and authorities to ensure reliable forward of information. You will have… Years of experience in registration activities and quality assurance preferably to international medical device regulations. Microsoft Excel, SAP and general IT literacy. Knowledge of ISO 9001, ISO 13485 and Medical Device Directive ideally. Knowledge of national medical device regulations. What you will be doing… Support implementation, development and maintenance of quality management system according to international standards. Manage customer complaints handling and instructed actions e.g. product blockings, recalls, providing field safety notices, etc. Responsibility for product registration on the market in accordance with local legal requirements; main contact for the local competent authority and responsibility for the maintenance of the business in the local market. Assure an effective, consistent and reliable forward of information in terms of product surveillance on the local market in accordance with legal requirements. Support the internal and external audits. Continuous communication with QA/RA EMEA.