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Associate II, Complaints (Korean Speaker)

alcon · Selangor

🇬🇧 English

Job description

About the role

Alcon is seeking an Associate II to manage regulatory reporting and complaint handling for its eye‑care portfolio. The role focuses on day‑to‑day submission of medical device safety reports and the end‑to‑end management of quality, technical and adverse event complaints, ensuring compliance with local Korean regulations and international standards.

Key responsibilities

  • Prepare and submit initial, follow‑up and final regulatory reports to Korean health authorities for medical devices, pharmaceuticals and OTC products.
  • Coordinate with internal teams and regulators to gather missing information, investigate late reporting, and implement corrective actions.
  • Manage daily complaint cases: intake, acknowledgement, triage, system entry, and issuance of final responses.
  • Act as subject‑matter expert on local regulations, support audit activities, and drive continuous process improvements.
  • Track performance metrics, identify compliance gaps, and ensure readiness for inspections and audit closures.

Required profile

  • Fluent Korean language skills.
  • Experience in regulatory reporting and complaint handling for medical devices or pharmaceutical products.
  • Strong knowledge of local Korean regulatory requirements and international guidelines.
  • Ability to investigate issues, determine root causes, and implement corrective actions.
  • Detail‑oriented with a focus on compliance and quality.

Required skills

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    Published 4 months ago

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    alcon

    Selangor