IPN ( is a highly specialized institute in the development of science-based projects at national and international level, with strong participation in activities of technology transfer, consultancy and stimulation in the creation of spin-off companies. IPN's Laboratory for Automation and Systems (IPNlas) develops projects in areas such as medical devices development, validation, and regulatory support. IPNlas is looking for candidates to integrate their Medical Devices Regulatory support unit (MDRu). Job position open: Medical Devices Regulatory Affairs Specialist Functions: Regulatory support for medical devices (CE, FDA, etc ...) Implementation of ISO 13485 Quality Management Systems Definition of Risk Management procedures according to ISO 14971 Implementation of Medical devices Usability tests Technical File submission to Notified Bodies Medical devices registration within the competent authorities Offer: Competitive salary based on experience Dynamic and innovative work environment Possibility of integrating international projects Opportunity of collaborating with innovative medical technology startups Continuous opportunities for professional development Requirements: Master's in Biomedical Engineering, Pharmaceutical sciences, Biological sciences or similar Proficient in English and Portuguese Knowledge and experience of 2 years (minimum) in: Regulation of medical devices (CE, FDA, etc…) Quality management systems definition (ISO 13485) Preparation of product's technical documentation Risk management and usability Medical devices registering procedures (within competent authority) Communication with Notified Bodies Preferential factors: Training in quality audits Transversal competencies: High sense of responsibility for objectives and meeting deadlines Excellent communication and collaboration skills, including the capability of communicating technical concept with technical and non technical stakeholders Capability of leading and working in collaboration in a team of professionals with different backgrounds and expertises Strong problem-solving and critical thinking skills for identifying potential risks and proposing efficient solutions; Adaptability and flexibility to work in a dynamic and fast paced environment with variable priorities and requirements Positive attitude, motivation and will to learn and improve Attention to detail and commitment to high quality work Apply until: 30 th September to with the reference IPN/LAS/2024/CON4 #J-18808-Ljbffr