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Work Setup: Hybrid Setup, Cebu City (Onsite during training period)

Work Schedule: Night Shift

Responsibilities:

• Serve as a Subject Matter Expert, providing insight and guidance on ophthalmic products and procedures to both internal teams and external stakeholders.
• Oversee and mentor Customer Quality Specialists, ensuring that they deliver exceptional service and maintain high-quality standards.
• Engage in governance and business reviews, presenting findings and updates as required, assisting in key decision-making processes.
• Conduct training for new team members, ensuring they have the knowledge and resources necessary to succeed in their roles.
• Manage Medical Device Complaints for Surgical Vision Care, ensuring compliance and thoroughness in all complaint handling procedures.
• Handle approximately 500 complaint files monthly, ensuring prompt processing in accordance with company protocols, including coding and reportability determinations.

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• In-depth understanding of Regulatory Reporting procedures and standards.
• Responsible for generating regulatory reports for events deemed reportable, ensuring compliance and accuracy in all submissions.
• Draft and submit an estimated 70 regulatory reports from the APAC region to relevant health authorities, utilizing effective complaint management systems.
• Prepare approximately 100 monthly Vigilance reports from the EMEA region, ensuring all diligent processes are followed.
• Manage the drafting and submission of 200 Medical Device Reports (MDRs) as required according to company guidelines.
• Conduct Literature Review effectively, analyzing articles to determine relevance and implications.
• Evaluate literature articles submitted via various channels, assessing their impact on company practices and product safety.
• Utilize the Buyer complaint management system to perform literature reviews and handle intake processes effectively for identified events.
• Ensure complete and up-to-date records are maintained by reviewing recent literature articles and integrating new information into existing processes.

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Qualifications

• A degree from a recognized institution in an Allied Health field is required. Candidates who have specialized training or certifications related to Ophthalmology or Optometry will be viewed favorably.
• A minimum of 6 months to 2 years of applicable experience in Ophthalmology, Optometry, or Surgical Vision Care is required, showcasing your ability to navigate within this specialized field.
• Prior exposure to Health Authority Reporting is preferred, as it demonstrates familiarity with regulatory environments and compliance standards.
• Experience in Medical Writing is advantageous, illustrating your ability to communicate complex medical information effectively.
• Familiarity with Medical Device Complaint Handling will be necessary for success in this role, enabling you to contribute to critical processes in the healthcare sector.