Job Opportunity: Medical Devices Regulatory Affairs Technician (M/F)
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The Automatics and Systems Lab (LAS) was awarded several Horizon Europe Projects and is looking for candidates who want to embrace the challenge of implementing these projects and support the digitalization of health in Portugal.
Job position: Medical Devices Regulatory Affairs Technician
Main tasks:
The Automatics and Systems Lab (LAS) was awarded several Horizon Europe Projects and is looking for candidates who want to embrace the challenge of implementing these projects and support the digitalization of health in Portugal.
Job position: Medical Devices Regulatory Affairs Technician
Main tasks:
- Implementation of ISO 13485 Quality Management Systems;
- Regulatory support for medical devices and or in vitro diagnostics (CE, FDA, etc);
- Definition of risk management and usability procedures;
- Medical devices and in vitro diagnostic medical devices registration within the competent authority;
- Systems and product auditing.
- Employment contract;
- Wage according to the experience of the candidate;
- Continuous training aligned with profile;
- Opportunity for internal growth according to demonstrated skills;
- Integration in a young and dynamic team that promotes a friendly environment of respect, trust, transparency and informality;
- Be engaged in international projects in all stages (from planning to execution);
- Possibility of international experience;
- Integration in a recognized institution;
- Opportunity to apply previous knowledge and experience.
- Master’s in health sciences, Pharmaceutical sciences, Biological sciences or similar;
- Proficient in English and Portuguese;
- Knowledge and experience of 1 year (minimum) in:
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Quality management systems definition (ISO 13485)
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Regulation of medical devices and/or in vitro diagnostics (CE, FDA, etc)
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Preparation of product’s technical documentation
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Risk management and usability
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Medical devices registering Procedures (within competent authority)
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Training in quality audits
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Soft skills:
- Autonomy and orientation towards objectives and results
- High sense of responsibility
- Good communication skills
- Teamwork skills
