06/30/2023 updated
partially available
info: Available evenings and weekends
Regulatory Affairs Specialist (Medical Devices)
Portugal
Only remote
MSc in Biomedical Engineering; PhD in Health SciencesFundamental ScienceBiomedical EngineeringMedical ResearchBiomedical SciencesBiomedical TechnologyClinical WorksClinical ResearchHealth SciencesISO 13485ISO 14971Quality ManagementImagingMedical MaterialRegulatory AffairsRisk Management
MSc in Biomedical Engineering, with specialization in Imaging and Radiation, and PhD in Health Sciences, field of Biomedical Sciences.
I am a Project Manager and Consultant in the area of Medical Devices Regulatory Affairs at the Laboratory for Automatics and Systems (LAS) at Instituto Pedro Nunes. I have extensive experience in the certification of medical devices and in vitro diagnostic medical devices according to European regulations (MDR and IVDR). Additionally, I also have experience in certifying MDs and IVDs in other territories such as the US, following FDA guidelines (510(k), De Novo Classification request...). On the subject of medical devices, I also have experience in Quality Management Systems implementation and certification, according to ISO 13485, as well as in Risk Management according to ISO 14971, and in the design of pre-clinical and clinical studies.
I also have extensive experience in Life and Health Sciences research, spanning from basic research to pre-clinical, translational, and clinical research. I am the author and co-author of 24 scientific papers and 154 abstracts.
I am a Project Manager and Consultant in the area of Medical Devices Regulatory Affairs at the Laboratory for Automatics and Systems (LAS) at Instituto Pedro Nunes. I have extensive experience in the certification of medical devices and in vitro diagnostic medical devices according to European regulations (MDR and IVDR). Additionally, I also have experience in certifying MDs and IVDs in other territories such as the US, following FDA guidelines (510(k), De Novo Classification request...). On the subject of medical devices, I also have experience in Quality Management Systems implementation and certification, according to ISO 13485, as well as in Risk Management according to ISO 14971, and in the design of pre-clinical and clinical studies.
I also have extensive experience in Life and Health Sciences research, spanning from basic research to pre-clinical, translational, and clinical research. I am the author and co-author of 24 scientific papers and 154 abstracts.
Experience
Professional experience0 - 5 years
Freelancer since2023
Languages
EnglishGoodFrenchFluentPortugueseNative speaker