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)