At Alcon, we are inspired by the meaningful work we do to help people see brilliantly. As the global leader in eye care, we boldly innovate, champion progress, and act with speed. We recognize and celebrate the contributions of our people, offering career opportunities that empower growth and fulfillment. Together, we go above and beyond to make a lasting impact on the lives of our patients and customers. We cultivate an inclusive culture and invite diverse, talented individuals to join us in shaping the future of eye care.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.Responsible for the daily case management 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. Complaint handling responsibilities reflect activities required to comply with local and international regulations, guidelines, and applicable directives.KEY RESPONSIBILITIES:For Medical Device Safety Reporting:Ensure required regulatory reports are complete and submitted on-timeFollow-up with internal functions and regulatory agencies to gather missing or required information to ensure compliance to requirementsPerform investigation for any late reporting, identify root-cause and implement required corrective actionsParticipate in internal and external audits as a subject matter expertTake ownership of the process and drive continuous improvements to enhance efficiency and effectivenessTrack required metrics for process oversight and escalate any issues as appropriateAct as the subject matter expert on local regulations and requirements to support Alcon product portfolioExercise judgment within defined procedures and practices to determine appropriate actionRecommend improvements to current practices and procedures.Support and collaborate to ensure country inspection readiness (internal and/or external). Support for and ensure timely closure of audits, corrective plan, investigation related to regulatory report.Proactive identify compliance issues and compliance gaps, follow up and timely closure of observations in close cooperation with regional and global.Ensure all processes, policies and procedures are clearly defined, fully documentedEnsure all processes comply with Alcon standards, policies, and applicable regulationsResponsible country(ies): China, Hong Kong, TaiwanFor Complaint Handling:Ensure compliance of the regional/country complaint handling process for all Alcon products, including intake, follow up and triage for reports of quality/technical complaints and Adverse Events in compliance with local and international regulations, guidelines and applicable directives.Receive initial complaint from any source (e.g. NotifEye, ECP, HCP, patients, internal/ external Alcon representatives) and ensure all information and data are accurately captured at the point of contactMaintain a thorough understanding of the information and data required to be collected for both technical and adverse event (AE) complaints to assure compliance with regulations and directivesManage technical and AE complaint records for assigned area(s) using designated safety system(s)Review potential complaint data received via safety system(s) and other methods, as required.Work efficiently across applicable time zones to support timely complaint handling.Performs all necessary reconciliation activities, including those related to customer oriented programs in accordance with proceduresTriage/ address calls from all sources regarding quality technical complaint, AEAdheres to required metrics for all complaint handling responsibilitiesCoordinate product return and shipping of samples to QA sites for further analysisClose files in accordance with established guidelines and within required timelinesMaintain working knowledge of the following:Company policies, departmental procedures, and applicable work instructionsEvolving local and international regulations, guidelines and applicable directivesAlcon products with assigned therapeutics area(s) and corresponding documentation (Product Inserts, Direction for Use (DFU), Manuals, Promotional Materials)Eye anatomy, common diseases, ophthalmic procedures, terminologyComplaint management system, safety database and reporting toolsPromptly inform management of potential safety issues, emerging trends and/or concerns. Ensure a business continuity plan is in place to guarantee uninterrupted availability of key vigilance processes and activities, or to mitigate the impact of an unwanted event through tested measures and procedures that enable efficient and effective business resumption and/ or recovery.Support, collaborate and ensure Country inspection readiness (internal and/or external). Support for and close out of audits, corrective plan, investigation, related to vigilance. Proactive identify compliance issues and compliance gaps, follow up and closure of observations in close cooperation with regional and global.Responsible country(ies): APAC and SEAKey Performance Indicators (KPI)Quality and timely reporting of KPI and customer responseComplaint and/or AE intake and safety reporting complianceNo critical findings in audits or inspectionsCustomer feedback and satisfactionHOW YOU CAN THRIVE AT ALCON:Education:Minimum Required: Graduation in SciencePreferred Level: University DegreeDesirable: university degree in optometry/ pharmacy/ ophthalmology/ medicine/ pharmacology/ biomedical science/ biomedical engineering/ chemistry/ biology/ nursing or other healthcare disciplineLanguages:Fluent in both written and spoken English & Mandarin​Key Competencies/Behaviours:Results Driven and Technically Competent.Customer / Quality FocusEmpowerment / AccountabilityMutual Respect / Trust / LoyaltyExperience:Minimum 2 year of experience in pharmaceutical and medical device industriesProven ability in implementing quality and documentation systems.Record of accomplishment of tracking complaints and safety reportingEffective communicatorExperience working within multinational pharma companies or medical device company desirableComprehensive understanding of national and international regulations for medical device vigilance and pharmacovigilance, medical terminologyHOW YOU CAN THRIVE AT ALCON:Opportunity to work with a leading global medical device companyCollaborate with a diverse and talented team in a supportive work environmentCompetitive compensation package and comprehensive benefitsContinuous learning and development opportunitiesAlcon CareersSee your impact at alcon.com/careersATTENTION: Current Alcon Employee/Contingent WorkerIf you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
