AI Medical Technology seeks QA/RA to Stockholm

INTRODUCTION
AI Medical Technology has developed an AI based decision support system to diagnose different types of skin lesions. Together with continued software development and clinical studies, the company is now ready to begin implementing the necessary quality systems to be able to obtain the CE mark. Therefore, AI Medical Technology is now looking for a Quality Assurance and Regulatory Affairs Manager (QA/RA). The employment is a fixed-term employment of 12 months, in Stockholm, and starts on 15 September 2021 and ends on 15 September 2022. The employment is full-time 40 hours per week. In the position of QA/RA Manager, the employee is responsible for the development and implementation of the Quality Management System (QMS) and regulatory compliance of the organization and its medical device software and products. The employee shall carry out the following activities.


THE EMPLOYMENT INVOLVES:
Collaborate with relevant partners and consultants regarding the development and implementation of QMS.
Ensure that the quality system requirements are effectively established and maintained in accordance with all applicable medical device regulations, including, ISO 13485, and other standards.
Monitor and report on Quality objectives and Key Performance Indicators.
Compile and maintain product Technical Files for initial and ongoing certification.
Contribute to strategic planning and implementation of Regulatory and Quality aspects of the business.
Coordination of post-market activities e.g., surveillance, customer feedback, failure analysis.



YOUR PROFILE
For the position, it is necessary that the candidate has the corresponding professional experience and education
University education and master's degree in one of the areas of health, medicine, biomedicine, medical technology, project management, entrepreneurship, medical biology, and pharmacology.
Knowledge and work experience in the development and implementation of quality systems, merit is knowledge obtained from corresponding tasks with medical technology products.
The company is looking for a person with distinctive qualities such as drive, accuracy, and eye for detail in writing, team player, responsible, social, and solution-oriented.



WHY APPLY TO OUR COMPANY
The company is at the forefront of research and development in its field. The company develops tomorrow's technology that streamlines healthcare processes and ultimately saves lives. For you who want to take part in this journey to improve healthcare and with the company and its employees grow and develop. For you who are looking for a high-performing workplace, this is an opportunity that the company invites you to.
HOW TO APPLY
You apply for the job by sending your CV and personal letter no later than 5 August 2021 to christoffer@aimedtech.org
ABOUT THE COMPANY
AI Medical Technology uses artificial intelligence to improve people's lives and revolutionize healthcare with medical image analysis. Our mission is to provide physicians with decision support in diagnosing life-threatening diseases with higher precision than traditional methods. The company's first application is a clinical decision support system that will support general practitioners in early skin cancer prevention.