EU MDR/EUDAMED Quality Systems Lead

Johnson Johnson; Ireland; On-site; EUR 83,000 - 138,000; Full time

Job summary

Johnson & Johnson MedTech seeks a Senior/Staff EUDAMED Quality Engineer to lead EU MDR and EUDAMED compliance across the organization. You will own QMS documentation, risk management, and data governance while coordinating cross-functional teams in Regulatory, Quality, Supply Chain, Vigilance, and Clinical.

You will drive process harmonization, lifecycle management, and deployment readiness for EUDAMED modules, ensuring scalable, compliant operations across sectors.

Qualifications

• 7+ years in Medical Devices or Life Sciences within Quality Systems, Regulatory Affairs, Data Management, or Process Excellence.
• Direct experience with EU MDR and EUDAMED module deployments.
• Hands-on experience with Data Governance, Master Data Management (MDM), and data quality tools.

Responsibilities

• Maintain EUDAMED QMS documentation, standards, work instructions, quality plans, and training curricula to ensure continuous alignment with EU MDR.
• Lead compliance reviews, gap assessments, internal/external audits, CAPA, change control, risk management, and organizational changes.
• Evaluate EU MDR/EUDAMED updates to assess cross-module risks and implement quality system adjustments.
• Establish end-to-end process workflows, role descriptions, and data governance frameworks for data accuracy and lifecycle compliance.
• Lead process improvement initiatives to standardize EUDAMED operations across sectors and franchises.
• Act as lead business analyst to gather cross-functional requirements, translate regulatory rules into operational controls, and design scalable operating models.
• Evaluate new EUDAMED functionality/releases, coordinate user testing, and handle system outage responses.
• Oversee user access governance, training delivery, and readiness for upcoming module deployments.
• Manage internal/external EUDAMED communication and provide guidance to operational teams.

Skills

Cross-functional leadership

Quality Systems

Regulatory Affairs

Data governance

Process design

Risk management

CAPA

Change control

Data mapping

Stakeholder management

MDM

Data quality tools

EU MDR knowledge

EUDAMED modules

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

QMS software

Data governance tools

Job description

Johnson & Johnson MedTech seeks a Senior/Staff EUDAMED Quality Engineer to lead EU MDR and EUDAMED compliance across the organization. You will own QMS documentation, risk management, and data governance while coordinating cross-functional teams in Regulatory, Quality, Supply Chain, Vigilance, and Clinical.

You will drive process harmonization, lifecycle management, and deployment readiness for EUDAMED modules, ensuring scalable, compliant operations across sectors.