QA/RA Manager
Pale Blue Dot®Recruitment LimitedGalway, Ireland
Posted August 14, 2025
Contract / Temporary
About the Company
Pale Blue Dot® Recruitment is a leading specialist recruitment agency focused on connecting high-caliber talent with top organizations in MedTech, Life Sciences, Digital Health, and STEM-based Manufacturing across Ireland. With a people-first approach and deep industry knowledge, the company offers tailored recruitment strategies that prioritize long-term fit, culture alignment, and business impact. Services include permanent and contract recruitment, executive search, and technical recruitment, all delivered from their base in Galway.
Job Description
We are seeking an experienced QA/RA Manager with a strong Design Assurance focus to join an exciting early-stage medical device company. The role involves leading design control processes, driving regulatory compliance, and acting as a bridge between R&D and quality.
Requirements
- Bachelor's Degree in Engineering, Life Sciences, or a related field
- 10+ years' experience in Quality Assurance, Regulatory Affairs, or Design Assurance within a medical device environment
- Deep knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971
- Demonstrated experience managing Design History Files and leading design control processes
- Firsthand experience of regulatory authority audits
- Strong track record in team building, stakeholder management, and cross-functional collaboration
Benefits
- Competitive contractor day rate based on experience
- The chance to make a genuine impact at a critical stage of product development
- Collaborative, purpose-driven team culture
- A role where your expertise directly shapes patient outcomes
