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Project Manager - IVDR

  • Sector: Science & Pharma
  • Contact Email: colin.byrne@collinsmcnicholas.ie
  • Job Ref: 22402

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.

Education:

  • 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.

colin.byrne@collinsmcnicholas.ie

071-9140255