Job opportunity: Medical Devices Regulatory Affairs Specialist (M/F)
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Instituto Pedro Nunes (IPN) is expanding its team and is looking for a Medical Devices Regulatory Affairs Specialist to integrate the team of the Automatics and Systems Lab (LAS).
Functions:
Instituto Pedro Nunes informs that the personal data provided by candidates within the scope of this recruitment procedure will be used exclusively for the assessment of applications. The data will be processed in accordance with our Data Protection and Privacy Policy. Instituto Pedro Nunes is responsible for the processing of personal data, namely that sent by candidates in the context of this recruitment procedure. The data of non-selected candidates will be deleted after the end of the process, unless they consent to retention for future opportunities or legal obligation. Candidates have the right to access, rectify, erase, limit, oppose the processing and request the portability of their data, and may exercise these rights via the following e-mail address: rgpd-ipn@ipn.pt. For more information, please consult our Data Protection and Privacy Policy.
Instituto Pedro Nunes (IPN) is expanding its team and is looking for a Medical Devices Regulatory Affairs Specialist to integrate the team of the Automatics and Systems Lab (LAS).
Functions:
- Regulatory support for medical devices (CE, FDA);
- 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.
- Competitive salary based on experience;
- Dynamic and innovative environment;
- Possibility of integrating international projects;
- Opportunity of collaborating with innovative medical technology startups;
- Continuous opportunities for professional development.
- Master’s degree in Biomedical Engineering, Pharmaceutical Sciences, Biological Sciences or similar areas;
- Proficient in English and Portuguese;
- Minimum of 2 years of knowledge and experience in:
- Regulation of medical devices (CE, FDA);
- 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.
- 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;
- High sense of responsibility for objectives and meeting deadlines;
- Excellent communication and collaboration skills, including the capability of communicating technical concepts with technical and non technical stakeholders;
- Capability of leading and working in collaboration in 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.
Instituto Pedro Nunes informs that the personal data provided by candidates within the scope of this recruitment procedure will be used exclusively for the assessment of applications. The data will be processed in accordance with our Data Protection and Privacy Policy. Instituto Pedro Nunes is responsible for the processing of personal data, namely that sent by candidates in the context of this recruitment procedure. The data of non-selected candidates will be deleted after the end of the process, unless they consent to retention for future opportunities or legal obligation. Candidates have the right to access, rectify, erase, limit, oppose the processing and request the portability of their data, and may exercise these rights via the following e-mail address: rgpd-ipn@ipn.pt. For more information, please consult our Data Protection and Privacy Policy.
