APAC Quality & Regulatory Lead – Ophthalmic Lenses

EssilorLuxottica; Singapore; On-site; SGD 80,000 - 120,000; Full time

Benefits offered by this job

Employee Shareholding

Flexible working

Paid days off

Happiness Committee (Singapore)

OneSight EssilorLuxottica Foundation

Medical benefits

Job summary

EssilorLuxottica in Singapore seeks a Quality and Regulatory Leader to own product quality and regulatory compliance for OSA’s lens products across APAC. You will manage new product introductions, drive CAPA, and support regulatory submissions with authorities such as FDA and MOH.

This role also acts as QMR for ISO 13485 QMS, collaborating with factories, suppliers and regulatory teams. You will monitor regulatory changes across APAC markets, prepare quality agreements, assess risk across the

Qualifications

• Degree in Science, Engineering, Quality, Regulatory Affairs or a related field.
• About 5 years of experience in quality and/or regulatory roles, preferably in medical devices, ophthalmic lenses or optical products.
• Working knowledge of ISO 13485 and QMS processes, including document control, internal audits and CAPA.
• Familiarity with APAC regulatory requirements and product registration (e.g. FDA, MOH, CE).
• Experience handling customer complaints, root cause analysis and corrective/preventive action.
• Understanding risk assessment and change control across the product lifecycle.
• Ability to review and prepare technical and regulatory documents (test reports, technical files, IFU, labelling).
• Strong communication and coordination skills for working with factories, suppliers, customers and regulatory teams.
• Strong attention to detail, organization and follow-through across multiple projects and deadlines.
• Proficiency in MS Office, and willingness to work with overseas partners and travel when needed.

Responsibilities

• Manage new product introduction through to release for order processing, including preparing Product Specs, the Range file and the OPC template.
• Obtain test reports from factories per APAC Regulatory’s minimum requirements, and ensure a complete set is ready for approval.
• Manage customer complaints end to end: clarify the defect and batch traceability, give timely responses and containment actions, coordinate returns and investigation with factories, and follow up on credit notes.
• Drive root cause investigation and CAPA, verify their effectiveness, and keep complaint records documented. Review complaint trends and market feedback to recommend improvements.
• Monitor regulatory changes across APAC markets and assess their impact on products, labelling and technical documentation.
• Support customers’ product registrations
• Prepare Quality Agreements and other compliance documents (e.g. Indemnity Agreement, Certificate of Compliance) with factories and customers.
• Assess and mitigate risk for product, supplier or manufacturing changes throughout the product lifecycle, so safety and compliance are not compromised.
• Act as Quality Management Representative for the ISO 13485 QMS: control documents and records, support supplier evaluation, training, audits and management reviews, and report on QMS performance.

Skills

Quality management

Regulatory affairs

APAC regulatory

Communication

Coordination

Attention to detail

MS Office

Education

Bachelor's or equivalent in Science/Engineering/Quality/Regulatory

Job description

EssilorLuxottica in Singapore seeks a Quality and Regulatory Leader to own product quality and regulatory compliance for OSA’s lens products across APAC. You will manage new product introductions, drive CAPA, and support regulatory submissions with authorities such as FDA and MOH.

This role also acts as QMR for ISO 13485 QMS, collaborating with factories, suppliers and regulatory teams. You will monitor regulatory changes across APAC markets, prepare quality agreements, assess risk across the