QA/RA Manager 

9 Month Contract opportunity 

About Your New Employer

• 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.

About Your New Job

• 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.

What Skills You Need

• 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.

What's on Offer

• 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.

What's Next

Apply now by submitting your CV to rkeyes@sigmar.ie. If you have questions or would like to discuss the position further, please reach out, we look forward to hearing from you!

If this job isn’t quite right but you’re interested in similar roles in QA/RA or Design Assurance, please get in touch to learn more about other opportunities.