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)