Line management of project managers and development scientists within the department Resource management and planning, e.g. budgeting, human resource allocation, etc. Strategic and technical evaluation for new project scouting and development. Communicate regularly and effectively with researchers, clinicians and industry to conceptualize and design novel, clinically relevant and commercially viable medical device products. Work with both internal and external stakeholders to define project plans and budgets, develop and maintain project timelines, establish and monitor project risks and risk register and lead the project teams to achieve project deliverables and objectives in accordance to ISO 13485. Evaluate, initiate and execute medical device product development projects of various developmental stages towards commercialization. Communicate regularly and effectively with researchers, clinicians The candidate is required to: Line management of project managers and development scientists within the department Resource management and planning, e.g. budgeting, human resource allocation, etc. Strategic and technical evaluation for new project scouting and development. Communicate regularly and effectively with researchers, clinicians and industry to conceptualize and design novel, clinically relevant and commercially viable medical device products. Work with both internal and external stakeholders to define project plans and budgets, develop and maintain project timelines, establish and monitor project risks and risk register and lead the project teams to achieve project deliverables and objectives in accordance to ISO 13485. Evaluate, initiate and execute medical device product development projects of various developmental stages towards commercialization. Communicate regularly and effectively with researchers, clinicians Requirements: Technical Skills: Subject matter expert in molecular diagnostics with a solid comprehension of the key industry trends and competitive landscape. Knowledge and track records in molecular diagnostics development, pilot and scale-up manufacturing, analytical verification, and clinical validation. Experience in applying design control and phase gate-driven product development processes for the development of molecular diagnostics assays and systems under ISO 13485. Experience in managing development projects in an IVD setting, as well as multi-project experience is highly desired Good understanding of applicable IVD medical device regulations, FDA design control process, and ISO 13485 standards preferred Soft Skills: Experience in stakeholder management and alignment in public institution settings. Resourceful, strong communication and adaptability in a fast-paced environment. Leadership experience and ability to coach and train team members Experienced in originating and building strategic partnerships. Qualifications: Advanced education degree or equivalent in Life Sciences, Biotechnology or related field supported 10+ years of similar experience Company information Registration No. T08GB0002C Report this job advert Don't provide your bank or credit card details when applying for jobs. Researching careers? Find all the information and tips you need on career advice. #J-18808-Ljbffr
