PbCompany Description /b /ppVelferd, through its brand VLF Consulting, is an innovative multi-services hub dedicated to supporting companies in the development of groundbreaking solutions in the devices and pharmaceutical sector. The company specializes in Regulatory Affairs and Quality Assurance, with expertise across medical devices, food supplements, and cosmetics. Velferd provides customized assistance for quality system implementation, regulatory compliance, product development, testing, and post-market activities. With a focus on delivering technical excellence and tailored training, Velferd ensures clients meet industry standards and regulations. The organization fosters innovation and quality to drive success in the healthcare and pharmaceutical sectors. /ppbr/ppbRole Description /b /ppThis is a freelance, contract-based, and fully remote role for a Software and Active Devices Consultant at Velferd srl. The consultant will provide expert advice, guidance, and technical solutions to different Clients. Core responsibilities include supporting software design and development, ensuring compliance with relevant medical and technical standards, collaborating on technical requirements, and creating or reviewing documentation. Additionally, the consultant will contribute to implementing best practices for software and active device-related projects, including debugging, database management, and process optimization. /ppbr/ppbQualifications /b /pulliProven expertise in Software Consulting and general consulting practices /liliFamiliarity with regulatory standards for medical devices and active device software (b62304, 60601 /b) /liliExperience with bISO 27001 /b (Information security, cybersecurity and privacy protection) is a plus /liliExcellent problem-solving skills and ability to work independently in a remote setup /liliRegulatory knowledge of bMDR 2017/745 /b and bFDA regulations /b for the US market. /liliBachelor’s or Master’s degree in Computer Science, Biomedical Engineering, or a related field /li /ulpbr/ppbWhat we offer: /b /pulliA fully remote collaboration with flexible activity management. /liliIntegration into a dynamic and innovative environment focused on quality and regulatory compliance. /liliThe opportunity to actively contribute to the development and improvement of company processes. /li /ulpbr/ppbNote: Only applications that meet the required qualifications will be considered. /b /p