Associate II, Complaints (Mandarin Speaker)
alcon · Selangor – AGS
Job description
About the role
Alcon is seeking an Associate II to manage regulatory reporting and complaint handling for its eye‑care products. The role requires daily coordination with internal teams and external health authorities to ensure timely, accurate submissions and effective resolution of quality and adverse‑event cases. Mandarin language proficiency is essential for supporting markets in China, Hong Kong, and Taiwan.
Key responsibilities
- Prepare and submit initial, follow‑up, and final regulatory reports for medical devices to local health authorities.
- Manage end‑to‑end complaint records, including intake, acknowledgement, triage, system entry, and final response.
- Coordinate with internal functions and regulators to gather missing information and ensure compliance.
- Investigate late reporting incidents, identify root causes, and implement corrective actions.
- Participate in internal and external audits as a subject‑matter expert.
- Track process metrics, drive continuous improvements, and support inspection readiness.
- Identify compliance gaps and work with regional/global teams to close observations.
Required profile
- Fluent Mandarin (spoken and written) for communication with China, Hong Kong, and Taiwan stakeholders.
- Experience in regulatory reporting and complaint handling for medical devices or pharmaceutical products.
- Strong knowledge of local and international regulations governing device safety and adverse events.
- Ability to conduct investigations, root‑cause analysis, and implement corrective actions.
- Excellent organizational skills and attention to detail.
Required skills
What we offer
- Opportunity to work with a global leader in eye care.
- Collaborative, inclusive culture that supports professional growth.
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Published 1 month ago
Expires 1 week from now
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alcon
Selangor – AGS
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