Freelance Software and Active Devices Consultant

7 giorni fa

Livorno, Italia VLF Consulting A tempo pieno

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.

This is a freelance, contract-based, and fully remote role for a Software and Active Devices Consultant at Velferd srl. 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.

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

A fully remote collaboration with flexible activity management.
Integration into a dynamic and innovative environment focused on quality and regulatory compliance.

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