Quality and Regulatory Director
Morgan McKinley View all jobs
- Galway
- Permanent
- Full-time
experienced Director of Quality Assurance & Regulatory Affairs to join its senior leadership
team.
As Director of QA/RA, you will own and lead the company's Quality Assurance and
Regulatory Affairs strategy and execution - from development through commercial approval
and post-market surveillance.
You will serve as a key member of the management team, shaping regulatory strategy,
building scalable quality systems, and ensuring global compliance as the organisation
advances through clinical development and commercialisation.Key Responsibilities
● Full ownership of the QA and RA functions across all processes leading to
commercial approval and post-market activities
● Act as Person Responsible for Regulatory Compliance (PRRC) under EU MDR
2017/745
● Monitor global regulatory agency actions and proactively adapt strategy to regulatory
changes
● Support development and validation of test methods
● Oversee manufacturing quality controls (inspection standards, plans, test methods,
frequencies)
● Lead Quality System audit processes and ensure traceability across design stages
● Support planning and execution of clinical development programs, including:
● Ensure clinical regulatory obligations including vigilance and safety reporting
● Prepare and maintain regulatory documentation for global submissionsExperience & Qualifications
● Primary degree in Science, Engineering, or a related discipline
● Minimum 10 years' experience in medical devices within Quality, Regulatory, or
Design Assurance roles
● Strong experience with Class II/III cardiovascular devices preferred
● ISO 13485 Lead Auditor qualification
● Clinical trial regulatory expertise
● Extensive experience in regulatory documentation and scientific literature analysis
● Proven leadership and people management capability
● Strong analytical mindset with the ability to challenge data, identify gaps, and
generate robust technical reports to support submissionsIf you are an experienced QA/RA leader looking to build and scale regulatory excellence
within an innovative medtech company, this role offers both challenge and significant career
impact.