Korea Quality & Regulatory Affairs Specialist

Mercor; Canberra; Hybrid; AUD 131,000 - 189,000; Full time

Job summary

Grifols, a global leader in healthcare, seeks a Quality Manager to oversee compliant distribution of medical devices and IVD products in Korea, maintain the affiliate's QMS, and act as the in-country contact for quality and regulatory matters reporting to Corporate Quality in Spain.

You will implement and improve the affiliate's Quality System, manage storage, shipping, licenses, supplier qualification, audits, recalls, CAPAs, and change controls, and collaborate with Regulatory, General Manager

Qualifications

• 3+ years in Quality or Regulatory roles within a multinational environment.
• Experience with medical devices or IVDs preferred.
• ISO 9001 quality system implementation/maintenance desirable.
• Pharmacy degree preferred.

Responsibilities

• Ensure compliant distribution of medical devices and IVD products.
• Maintain the affiliate's Quality Management System and act as local quality contact.
• Coordinate with regulatory bodies, customers, distributors and authorities.
• Qualify suppliers, perform audits and supplier assessments.
• Coordinate recalls, incidents, deviations, CAPAs and change controls.
• Attend audits and inspections and review promotional materials for regulatory perspective.
• Collaborate with Regulatory Specialist, General Manager and Corporate Quality.

Skills

Autonomy

Quality systems

English communication

Audits

Regulatory interactions

CAPA management

Escalation of issues

SAP experience

Education

Pharmacy degree

Tools

MS Office

SAP

Job description

Grifols, a global leader in healthcare, seeks a Quality Manager to oversee compliant distribution of medical devices and IVD products in Korea, maintain the affiliate's QMS, and act as the in-country contact for quality and regulatory matters reporting to Corporate Quality in Spain.

You will implement and improve the affiliate's Quality System, manage storage, shipping, licenses, supplier qualification, audits, recalls, CAPAs, and change controls, and collaborate with Regulatory, General Manager