QARA Manager

• Join an early-stage start-up based in Galway, dedicated to advancing patient solutions in palliative care.
• Be part of a passionate team driven to impact quality of life and fast-tracking disruptive medical device innovation for patients with late-stage cancers.
• Collaborate with leading clinical, academic, and manufacturing partners as the organization prepares to launch in global markets (US & Europe) and expands its technology into multiple therapeutic areas.

• As QA/RA Manager with Design Assurance Focus, you will lead and maintain Design Control processes to ensure compliance with global regulations (e.g. FDA 21 CFR Part 820, ISO 13485, EU MDR).
• Oversee the completeness and audit-readiness of all Design History File (DHF) documentation, driving robust implementation of design inputs, outputs, and verification/validation plans.
• Manage risk activities, usability engineering, and human factors integration across product development; support all aspects of test method validation, biocompatibility, and packaging integrity testing.
• Develop, implement, and maintain the Quality Management System (QMS), ensuring strong alignment with design controls and handling CAPA, deviations, and non-conformances related to design and development.
• Lead and host internal/external audits and regulatory inspections; prepare and support global regulatory submissions (FDA, CE) relating to product design.

• Bachelor’s Degree in Engineering, Life Sciences, or a related field.
• 10+ years of experience in Quality Assurance, Regulatory Affairs, or Design Assurance.
• Extensive experience supporting and leading regulatory audits (FDA and other authorities).
• Proven ability to develop and deliver effective training on Quality Systems and Processes.
• Track record in team building and influencing design decisions through data-driven insights.
• Hands-on experience with eQMS systems and strong cross-functional collaboration skills.

• Competitive daily/hourly contract rate for a 9-month assignment based in Galway.
• Opportunity to drive the quality and regulatory activities of game-changing medical solutions in a start-up entering a critical growth phase.
• Work in a fast-paced, multidisciplinary environment with exposure to commercialization, US market entry, and clinical innovation.

Sigmar Recruitment