Location: Galway, Ireland (On-site presence required: Full-time, with a flexible hybrid schedule (3 days on-site, 2 days remote))
This position serving as the most senior technical contributor on the project team. The role will lead design quality and project coordination, acting as the primary liaison between R&D, Quality, and Compliance to ensure project deliverables remain on track and meet regulatory and design requirements.
The project involves an iteration of an existing catheter-based medical device that is progressing into clinical trials, with the objective of transferring a commercial-ready version by the end of the year. The successful candidate will be embedded throughout the entire design and transfer process.
An overlap period is required, as the incumbent is expected to leave in May 2026.
Key Responsibilities
Act as the design quality lead, coordinating across R&D, Quality, and Compliance teams
Own and drive quality deliverables throughout the design and transfer phases
Review and approve project documentation in line with regulatory and design control requirements
Provide day-to-day support to R&D and Compliance on regulatory processes and standards
Manage the project jointly with an internal permanent team member who will provide support
Serve as the core point of contact for the project team, ensuring timelines and deliverables are met
Required Qualifications
Minimum education of degree in a technical field is preferred.
Minimum 3–5 years’ design experience, with proven exposure to end-to-end design control processes.
Demonstrated knowledge of the application of the principles, concepts and practices of design control, sterilization and Quality Assurance processes.
Experience in preparation, participation and response to external agency inspections e.g. FDA and Notified Body Inspections
Thorough knowledge of Design Control requirements and processes.
Working knowledge of 21 CFR 820, ISO13485 with familiarity of other foreign medical device quality system requirements.
Ability to handle multiple projects simultaneously and to discern major quality issues.
Ability to work well under deadlines and pressure.
Ability to work on own initiative and as a team player.
Ability to build good, strong and positive working relationships with cross functional teams internationally.
Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience.
Apply today and start your fulfilling career!
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