Associate Commercial Quality Manager (Medical Devices)

Location: Seoul, South Korea; hybrid work format. Limited travel, including occasional domestic travel within South Korea.

Company

Johnson & Johnson MedTech develops healthcare and medical device solutions, with this role supporting the DePuy Synthes orthopaedics business.

What you will do

• Lead Commercial Quality activities related to handling, storage, and distribution for the Korea market.
• Provide quality oversight for distribution, logistics, product disposition, shipment holds, and distribution-related quality decisions.
• Partner with Supply Chain, Commercial, Regulatory Affairs, and Global Quality teams on compliant product distribution, lifecycle management, license renewals, and regulatory documentation.
• Review and approve local labeling, electronic instructions for use, product information changes, UDI management, supply record reporting, and traceability activities.
• Coordinate post-market surveillance, complaint handling, field actions, recalls, and trend analysis.
• Monitor quality risks and performance metrics, drive corrective and preventive actions, and support audits and health authority inspections.

Requirements

• Bachelor’s degree in Quality, Engineering, Life Sciences, Regulatory Affairs, Supply Chain, or a related field.
• At least 8 years of progressive experience in Quality, Regulatory Affairs, or Compliance, including at least 5 years in Commercial Quality within the medical device industry.
• Experience with distribution, logistics, post-market quality activities, quality systems, regulatory expectations, audits, inspections, or regulatory assessments.
• Ability to analyze quality risks and translate regulatory requirements into practical actions.
• Korean is required. English proficiency is preferred.
• Familiarity with Korean regulatory and distribution quality requirements is preferred.

Nice to have

• Advanced degree in a scientific, quality, or regulatory field.
• Experience in healthcare or other highly regulated industries.
• Experience in a multinational or matrixed organization and prior coordination of HSD or Commercial Quality activities.
• Quality or Regulatory certifications such as ASQ or RAC.

Culture & Benefits

• Inclusive work environment guided by the company’s Credo.
• Hybrid work arrangement with limited travel.
• Opportunity to support patient safety, regulatory readiness, and reliable product supply.
• Employment may transition to DePuy Synthes following the planned separation of the Orthopaedics business, subject to required approvals and consultations.