Associate, Medical Device Safety Reporting (Korean 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.

Major Accountabilities

• 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
• Assist with complaints handling as needed.
• Responsible country(ies): South Korea

Key Performance Indicators (KPI)

• Prepare high quality regulatory reports for submission on or before assigned due dates
• Close collaboration with Alcon’s country patient safety lead and/or quality manager and/or regulatory manager in preparation and submission of regulatory inquiry
• No critical findings in audits or inspections

Associate is authorized:

• To submit product adverse event reports to the country Health Authority (HA) within timeline, leverage into the Quality Summary prepared by the Global Device Vigilance (GDV)
• To coordinate with the GDV colleagues for advice and clarification of any received Alcon's prepared responses, prior official submission
• To translate Alcon's response into local country language, and seek for country approval (when applicable) prior HA submission
• To coordinate with Alcon's Regaff team into the response to HA's inquiry within timelines

What You'll Bring To Alcon

• Tertiary qualification in optometry/ pharmacy/ ophthalmology/ medicine/ pharmacology/ biomedical science/ biomedical engineering/ chemistry/ biology/ nursing or other healthcare discipline.

Languages:

• Fluent in English and Bahasa Malaysia (spoken and written)
• Fluent in Korean (spoken and written)

Key Competencies/Behaviours:

• Technically Competent.
• Results Driven
• Customer / Quality Focus
• Empowerment / Accountability
• Mutual Respect / Trust / Loyalty
  

Experience:

• 1- 2 years of experience in pharmaceutical/chemical and medical device industries
• Proven ability in implementing quality and documentation systems.
• Record of accomplishment of tracking complaints
• Effective communicator
  

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
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