Project Manager
hace 4 días
Edinburgh
Project Manager - Diagnostics Hartmann Young is partnered with a global medical diagnostics company specialising in IVD that target autoimmune disease, allergy testing and transfusion medicine. They are going through a phase of expansion and are looking to grow their team in Edinburgh, UK, with the addition of a Project Manager. The Role: • Lead and coordinate the design, planning, and execution of assigned projects., • Manage cross-functional project teams within a matrix environment., • Organise and chair project meetings to ensure delivery milestones are met., • Manage external suppliers and partners to ensure successful delivery of project objectives., • Collaborate with Project Sponsors, Technical Leads, and team members to deliver projects in line with agreed plans., • Ensure all project activities and outputs comply with internal design control and project management procedures., • Communicate project goals, timelines, and progress effectively to stakeholders at all levels., • Identify, assess, and manage project risks, issues, and changes, implementing appropriate mitigation strategies., • Assist in training and mentoring staff in project management tools and methodologies., • Ensure all activities are conducted in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), and relevant regulatory requirements., • Undertake additional duties as required. The Person: • Bachelor’s degree in a scientific discipline or equivalent experience., • Proven project management experience, including managing multiple projects simultaneously., • Professional certification (e.g. PMP, PRINCE2, or equivalent) (Desirable), • Experience within regulated industries (e.g. medical devices, life sciences)., • Knowledge of IVDR or regulatory-focused projects. (Desirable), • Familiarity with ISO 13485 and/or relevant FDA regulations (e.g. CFR 820). (Desirable), • Understanding of design controls and regulatory submission processes (e.g. CE marking or FDA submissions). (Desirable)