Medical Devices Regulatory Affairs Specialist

IPN (https://www.ipn.pt) 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 SpecialistFunctions:Regulatory support for medical devices (CE, FDA, etc ...)Implementation of ISO 13485 Quality Management SystemsDefinition of Risk Management procedures according to ISO 14971Implementation of Medical devices Usability testsTechnical File submission to Notified Bodies Medical devices registration within the competent authorities Offer:Competitive salary based on experienceDynamic and innovative work environmentPossibility of integrating international projectsOpportunity of collaborating with innovative medical technology startupsContinuous opportunities for professional developmentRequirements:Master's in Biomedical Engineering, Pharmaceutical sciences, Biological sciences or similarProficient in English and PortugueseKnowledge 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 BodiesPreferential factors:Training in quality auditsTransversal competencies:High sense of responsibility for objectives and meeting deadlinesExcellent communication and collaboration skills, including the capability of communicating technical concept with technical and non technical stakeholdersCapability of leading and working in collaboration in a team of professionals with different backgrounds and expertisesStrong 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 requirementsPositive attitude, motivation and will to learn and improveAttention to detail and commitment to high quality workApply until: 30th September to ******  with the reference IPN/LAS/2024/CON4
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