QMS & Regulatory Lead – Medical Devices

Getinge Group; Dublin; Remote; EUR 90,000 - 120,000; Full time

Job summary

Getinge Ireland Ltd. is seeking a QRC Manager Ireland to maintain and improve a compliant Quality Management System (ISO 9001, ISO 13485), including audits, CAPAs and regulatory monitoring. The role supports the QRC Regional Director and acts as Local Quality Manager for Getinge Ireland.

The ideal candidate has 5+ years of hands-on Quality & Regulatory experience, strong MDR/EUMDR knowledge, and fluent English. This remote role requires collaboration across regions and departments.

Qualifications

• Bachelor degree in medical technologies, business administration or related field.
• Minimum 5+ years hands-on experience in Quality & Regulatory.
• Strong knowledge of MDR, UKMDR, MDD, EUMDR and other local regulations.
• Excellent language skills in English – verbal and written.
• Experience with ISO 13485 / ISO 9001 and CAPA processes.

Responsibilities

• Maintain and improve a compliant QMS (ISO 9001, ISO 13485).
• Lead internal and external audits and CAPA follow-up.
• Regulatory monitoring, product registrations, and import/export checks.
• Provide support to QRC Regional Director and act as Local Quality Manager for Getinge Ireland.

Skills

Quality management

Regulatory knowledge

Auditing

Communication

Leadership

Education

Bachelor degree in medical tech / related field

Job description

Getinge Ireland Ltd. is seeking a QRC Manager Ireland to maintain and improve a compliant Quality Management System (ISO 9001, ISO 13485), including audits, CAPAs and regulatory monitoring. The role supports the QRC Regional Director and acts as Local Quality Manager for Getinge Ireland.

The ideal candidate has 5+ years of hands-on Quality & Regulatory experience, strong MDR/EUMDR knowledge, and fluent English. This remote role requires collaboration across regions and departments.