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 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

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