Location
, selangor, malaysia
Job Type
Full-time
Posted
July 03, 2026
Job Description
POSITION OVERVIEW
Responsible for the day-to-day submission of regulatory reports (initial, follow‑up, and final) to local health authorities for medical devices. Works closely with the internal team and provides support as needed to ensure reports are complete, accurate, and submitted on time. Also manages daily case handling of quality, technical, and adverse event (AE) complaint records, including intake, acknowledgement, follow‑up, triage, system entry, and issuance of final responses for Alcon devices, pharmaceutical products, and over-the-counter products.
KEY RESPONSIBILITIES
- Medical Device Safety Reporting:
- Ensure required regulatory reports are complete and submitted on time.
- Follow up with internal functions and regulatory agencies to gather missing or required information.
- Perform investigation for any late reporting, identify root cause and implement required corrective actions.
- Participate in int...
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