Associate, Medical Device Safety Reporting (Mandarin Speaker)

At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

Job Overview

Responsible for day-to-day regulatory reports submission (Initial, follow-up and final) to local health authorities for medical devices. Close coordination with internal case processing and supporting, as needed to ensure the report is complete, accurate and on-time submission.

Key Responsibilities:

Ensure the required regulatory reports are submitted complete and on-time

Follow-up as needed with internal functions and regulatory agencies, to gather missing/required information to ensure compliance to requirements

Perform investigation for any late reporting, determine root-cause and implement required actions

Participate in internal and external audits as subject matter expert

Own the process, drive improvements to gain efficiency and effectiveness

Track required metrics to for process oversight and escalate any issues

Subject matter expert on local regulations and requirements to support Alcon portfolio of products

Exercise judgment within defined procedures and practices to determine appropriate action

Recommend changes to improve practices and procedures.

Support, collaborate and ensure Country inspection readiness (internal and/or external). Support for and close out of audits, corrective plan, investigation, related to regulatory report. Proactive identify compliance issues and compliance gaps, follow up and closure of observations in close cooperation with regional and global.

Ensure all processes, policies and procedures are clearly defined, fully documented

Ensure all processes comply with Alcon standards and policies

Responsible country(ies): China, Hong Kong, Taiwan

WHAT YOU’LL BRING TO ALCON:

Minimum: graduation in science.

Ophthalmology/ Eye care experience desirable

Desirable: university degree in optometry/ pharmacy/ ophthalmology/ medicine/ pharmacology/ biomedical science/ biomedical engineering/ chemistry/ biology/ nursing or other healthcare discipline.

Fluent in both written and spoken English & Mandarin

1-2 year of experience in pharmaceutical and medical device industries

Proven ability in implementing quality and documentation systems.

Record of accomplishment of tracking complaints

Effective communicator

Experience working within multinational pharma companies or medical device company desirable

Comprehensive understanding of national and international regulations for medical device vigilance and pharmacovigilance, medical terminology

HOW YOU CAN THRIVE AT ALCON:

Opportunity to work with a leading global medical device company.

Collaborate with a diverse and talented team in a supportive work environment.

Competitive compensation package and comprehensive benefits.

Continuous learning and development opportunities.

Alcon Careers

See your impact at alcon.com/careers

ATTENTION: Current Alcon Employee/Contingent Worker

If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.

Find Jobs for Employees

Find Jobs for Contingent Worker

R-2024-32711