Freelance Software and Active Devices Consultant
1 settimana fa
Company Description Velferd, 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. Role Description This 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. Qualifications Proven expertise in Software Consulting and general consulting practices Familiarity with regulatory standards for medical devices and active device software (62304, 60601) Experience with ISO 27001 (Information security, cybersecurity and privacy protection) is a plus Excellent problem-solving skills and ability to work independently in a remote setup Regulatory knowledge of MDR 2017/745 and FDA regulations for the US market. Bachelor's or Master's degree in Computer Science, Biomedical Engineering, or a related field What we offer: A fully remote collaboration with flexible activity management. Integration into a dynamic and innovative environment focused on quality and regulatory compliance. The opportunity to actively contribute to the development and improvement of company processes. Note: Only applications that meet the required qualifications will be considered.
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