Regulatory & Quality Lead (Maternity Cover)

Luminatemed; Galway; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Pension

Company laptop

Headphones

Camera

Job summary

Luminate Medical seeks a Quality Systems and Regulatory Manager (Maternity Cover) to support the medical device portfolio on a fixed-term contract starting August 2026. You will lead quality initiatives, ensure regulatory compliance, and collaborate across teams to bring high-impact devices to patients.

The successful candidate will have a Level 8 degree and at least 7 years in medical devices, with strong knowledge of FDA and ISO standards, and proven leadership in a fast-paced startup

Qualifications

• Level 8 degree or equivalent in engineering/Science/STEM/ASQ CQE.
• Minimum 7 years in Medical Device/Healthcare industry.
• Excellent working knowledge of Quality System Requirements in Medical Devices.
• Strong knowledge of FDA and ISO compliance.
• Ability to lead a team and work cross-functionally.
• Fluent in English with strong communication and planning skills.

Responsibilities

• Support introduction of new quality initiatives and new product introductions.
• Lead preventive and corrective actions for quality system deficiencies.
• Interface with other departments to ensure Quality system requirements are met.
• Provide management with reports on quality issues and implement solutions.
• Deliver and manage projects with internal and external stakeholders.
• Drive continuous improvement and challenge the status quo.
• Assess regulatory implications of device and process changes and ensure compliance.
• Lead preparation and submission of regulatory applications.
• Provide regulatory training and mentoring to cross-functional teams.
• Act as company representative with regulators and reviewers regarding submissions.
• Coordinate inputs for submissions and ensure timely license renewals and registrations.
• Recommend changes for labeling, manufacturing, and clinical reports for compliance.
• Support audit readiness and provide regulatory information to QA, notified bodies, authorities, and FDA.
• Research competitive regulatory approvals and share insights with stakeholders.

Skills

Quality Systems

Regulatory Affairs

Project Management

FDA Compliance

ISO Compliance

Leadership

English Proficiency

Education

Level 8 degree in engineering/Science/STEM/ASQ CQE

Job description

Luminate Medical seeks a Quality Systems and Regulatory Manager (Maternity Cover) to support the medical device portfolio on a fixed-term contract starting August 2026. You will lead quality initiatives, ensure regulatory compliance, and collaborate across teams to bring high-impact devices to patients.

The successful candidate will have a Level 8 degree and at least 7 years in medical devices, with strong knowledge of FDA and ISO standards, and proven leadership in a fast-paced startup