Associate II Complaints

Alcon; Selangor; On-site; MYR 60,000 - 80,000; Full time

Job summary

A global leader in eye care seeks an Associate II, Complaints in Malaysia. This role involves managing regulatory reports, handling quality complaints, and ensuring compliance with health regulations. The ideal candidate should have a science degree, 1-2 years in the medical device industry, and must speak English and Mandarin fluently. Opportunities for professional growth, a supportive team environment, and competitive compensation are offered.

Benefits

Competitive compensation package

Comprehensive benefits

Continuous learning and development opportunities

Qualifications

• 1-2 years of experience in pharmaceutical and medical device industries.
• Experience working within multinational pharma companies or medical device companies.
• Comprehensive understanding of regulations for medical device vigilance.

Responsibilities

• Submit regulatory reports to health authorities for medical devices.
• Manage quality, technical, and adverse event complaint records.
• Ensure compliance with local and international regulations.

Skills

Fluent in both written and spoken English

Fluent in both written and spoken Mandarin

Results Driven

Technically Competent

Customer Quality Focus

Education

Graduation in Science

University Degree in optometry/pharmacy/ophthalmology/medicine/pharmacology/biomedical science/biomedical engineering/chemistry/biology/nursing

Job description

Associate II, Complaints (Mandarin Speaker)

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.

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.

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.

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.

See your impact at alcon.com/careers.

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