The Junior Regulatory Affairs Specialist, reporting directly to our Regulatory Affairs Manager, will be responsible for:Ensuring that the software and algorithms developed by Digitec comply with all applicable regulations and laws in the countries of interestEnsuring that our products can be marketed within the timelines set by the organization and maintain their compliance throughout their lifecycle.His/Her main objectives will be:Acquiring full knowledge of Regulation (EU) 2017/745, ISO 13485 standard, and the standards applied to our products (ISO 14971 and IEC 62304)Drafting the technical documentation of our products,



ensuring compliance with current regulations and considering the company contextLearning to independently handle customers and address their regulatory inquiries.We are looking for candidates who stand out for:Problem-solving skillsProactivity and initiativeCustomer focusPrecisionCommunication skillsTeamworkLike everyone at Digitec, the Junior Regulatory Affairs Specialist will promote the core values of our culture, namely Integrity, Vision, Teamwork, Innovation, Leanthinking and Bright.The ideal profile, after obtaining a degree in Biomedical Engineering – or a related discipline – has gained an experience in a company, even briefly, in the regulatory field and must show interest in medical software.What we offer:Flexible working hours and opportunity to work from home (3Days/week and 1 full month remotely)Induction Challenging work environment, constantly evolvingTraining program to enhance technical and soft skillsPositive working environment where everyone is motivated to give his/her 100%Changing rooms and showers within Company premises that allow staff to train during their lunch breakFree coffee and company car park