Associate II, Complaints (Mandarin Speaker) job opportunity at Alcon.

Home Jobs In Malaysia Tag: Complaints (Mandarin Speaker) Associate II, Complaints (Mandarin Speaker) position at Alcon


DatePosted 30+ Days Ago bot
Alcon Associate II, Complaints (Mandarin Speaker)
Experience: 2-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Complaints (Mandarin Speaker)

Copy Link Report
degreeOND
loacation Selangor – AGS, Malaysia
loacation Selangor – AGS....Malaysia

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-time Follow-up with internal functions and regulatory agencies to gather missing or required information to ensure compliance to requirements Perform investigation for any late reporting, identify root-cause and implement required corrective actions Participate in internal and external audits as a subject matter expert Take ownership of the process and drive continuous improvements to enhance efficiency and effectiveness Track required metrics for process oversight and escalate any issues as appropriate Act as the subject matter expert on local regulations and requirements to support Alcon product portfolio Exercise judgment within defined procedures and practices to determine appropriate action Recommend 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 documented Ensure all processes comply with Alcon standards, policies, and applicable regulations Responsible country(ies): China, Hong Kong, Taiwan   For 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 contact Maintain 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 directives Manage 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 procedures Triage/ address calls from all sources regarding quality technical complaint, AE Adheres to required metrics for all complaint handling responsibilities Coordinate product return and shipping of samples to QA sites for further analysis Close files in accordance with established guidelines and within required timelines   Maintain working knowledge of the following: Company policies, departmental procedures, and applicable work instructions Evolving local and international regulations, guidelines and applicable directives Alcon products with assigned therapeutics area(s) and corresponding documentation (Product Inserts, Direction for Use (DFU), Manuals, Promotional Materials) Eye anatomy, common diseases, ophthalmic procedures, terminology Complaint management system, safety database and reporting tools Promptly 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 SEA   Key Performance Indicators (KPI) Quality and timely reporting of KPI and customer response Complaint and/or AE intake and safety reporting compliance No critical findings in audits or inspections Customer feedback and satisfaction HOW YOU CAN THRIVE AT ALCON: Education: Minimum Required: Graduation in Science Preferred Level: University Degree Desirable: university degree in optometry/ pharmacy/ ophthalmology/ medicine/ pharmacology/ biomedical science/ biomedical engineering/ chemistry/ biology/ nursing or other healthcare discipline Languages: Fluent in both written and spoken English & Mandarin ​ Key Competencies/Behaviours: Results Driven and Technically Competent. Customer / Quality Focus Empowerment / Accountability Mutual Respect / Trust / Loyalty Experience: 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

Other Ai Matches

Accounts Receivable Trainee with Nordic (Swedish, Norwegian, Finish) - Early Careers Program Applicants are expected to have a solid experience in handling Norwegian, Finish) - Early Careers Program related tasks
Responsable Scientifique et Formation - Vision Care CDD Applicants are expected to have a solid experience in handling Job related tasks
Sales Specialist - Surgical Applicants are expected to have a solid experience in handling Job related tasks
Sr. Associate I Customer Service Support (Customer and Pricing Master Data Administrator - Korean Speaker) Applicants are expected to have a solid experience in handling Job related tasks
Principal I, Software Engineering - Digital Health Applicants are expected to have a solid experience in handling Software Engineering - Digital Health related tasks
NPI / Process Engineer Applicants are expected to have a solid experience in handling Job related tasks
Inside Sales Representative (m/w/d) Applicants are expected to have a solid experience in handling Job related tasks
Operator II, Production Technical Operations - Phaco Secondaries (Sunday - Thursday, 10:30 PM EST - 6:30 AM EST) Applicants are expected to have a solid experience in handling Production Technical Operations - Phaco Secondaries (Sunday - Thursday, 10:30 PM EST - 6:30 AM EST) related tasks
Technician II, Chemical Production Operations Applicants are expected to have a solid experience in handling Chemical Production Operations related tasks
Sr. Associate, Quality Control Lab - Microbiology Applicants are expected to have a solid experience in handling Quality Control Lab - Microbiology related tasks
Sr Manager Talent Acquisition Operations Applicants are expected to have a solid experience in handling Job related tasks
Auto Process Machinist (Monday – Friday, 3:00 PM EST – 11:00 PM EST) Applicants are expected to have a solid experience in handling 3:00 PM EST – 11:00 PM EST) related tasks
Associate, Quality Assurance Applicants are expected to have a solid experience in handling Quality Assurance related tasks
remote-jobserver Remote
Account Manager-Manchester, NH Applicants are expected to have a solid experience in handling NH related tasks
Sr. Associate I, Surgical Field Sales Applicants are expected to have a solid experience in handling Surgical Field Sales related tasks
Manager I, Engineering Project Management Applicants are expected to have a solid experience in handling Engineering Project Management related tasks
Technical Service Administration Trainee ( Field Service Operations) - Early Careers Program Applicants are expected to have a solid experience in handling Job related tasks
OPERATOR Applicants are expected to have a solid experience in handling Job related tasks
Sr. Associate II, Surgical Field Sales Applicants are expected to have a solid experience in handling Surgical Field Sales related tasks
Sr. Associate I, Software Engineering Applicants are expected to have a solid experience in handling Software Engineering related tasks
Electro Mechanic Applicants are expected to have a solid experience in handling Job related tasks
Technician II, Quality Operations Applicants are expected to have a solid experience in handling Quality Operations related tasks
Sr. Associate I Customer Service Support (Customer and Pricing Master Data Administrator - Japanese Speaker) Applicants are expected to have a solid experience in handling Job related tasks