Our client, a leading global healthcare company based in Sligo is seeking a Project Manager to work on an IVDR project. This role will utilise a Hybrid working model.
IVDR (In Vitro Diagnostic Regulation) Project Manager - is responsible to successfully execute the management of the transition of Immunoassay (IA) and Clinical Chemistry (CC) medical device products to IVDR.
Core Job Responsibilities:
Leads internal CFT teams to support Technical Product Support, Regulatory and Quality functional areas and has direct regular contact with TPMs (Third-Party Manufacturer).
Lead the team through the translation of management and customer needs into project goals, define schedules, milestones, cost and resource requirements with management support.
Acts independently to identify and resolve problems, including identifying issues and risks and establishing appropriate action plans to mitigate project delay.
Manages multiple projects at one time and executes project timelines.
Implement process improvements to accelerate current and future project progress.
Develops accountability of team members through the execution of tasks; deliverables and milestones to assure product readiness.
Ensures that Design Control and Compliance requirements are met.
Communicates summary of product launch activities highlighting project changes and factors critical to success.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Skills and Qualifications:
Proven expertise in managing medium to large-scale projects.
Highly organised and detail-oriented with strong communication skills.
Experience with project management tools, particularly Microsoft Project .
Previous project management experience in regulatory affairs or clinical trials would be highly beneficial.
Bachelor’s degree in a technical or scientific discipline or equivalent experience relevant to the project arena preferred.
Knowledge of regulations and standards affecting IVDs and Biologics. Knowledge of EU Invitro Diagnostics Regulation 2017/746 a plus, but not necessary.
Project Management Professional (PMP) or Lean Six Sigma (LSS) certification considered a plus.
Minimum Experience / Training Required:
Minimum of 5 years project management experience (or equivalent) with at least 3 years’ experience leading projects involving the application of general business principles.
Demonstrated ability to work in a large/complex company environment preferred.
Technical, manufacturing, quality, or supply chain experience in a health care/medical company considered a plus.
Ability to work in a highly matrixed and geographically diverse business environment.
For a confidential discussion and more information on the role, please contact Colin Byrne.