Quality & Regulatory Assistant Manager

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

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If you’ve worn a pair of glasses, we’ve already met.

We are a global leader in the design, manufacture, and distribution of ophthalmic lenses, frames, and sunglasses. We offer our industry stakeholders in over 150 countries access to a global platform of high-quality vision care products (such as Varilux, Crizal, Stellest) , iconic brands that consumers love (such as Ray-Ban, Oakley, Oliver Peoples) , as well as a network that offers consumers high-quality vision care and best-in-class shopping experiences (such as Sunglass Hut, LensCrafters, the GrandVision network) , and leading e-commerce platforms.

Join our global community of over 190,000 dedicated employees around the world in driving the transformation of the eyewear and eyecare industry.

Discover more by following us on LinkedIn!

Your #FutureInSight with EssilorLuxottica

Are you willing to pioneer new frontiers, foster inclusivity and collaboration, embrace agility, ignite passion, and make a positive impact on the world?

Join us in redefining the boundaries of what’s possible!

Your role

You own the product quality and regulatory compliance for OSA’s lens products across APAC. It covers new product introduction through order release, handling customer complaints, and supporting customers’ product registrations with authorities such as the FDA and MOH. The role also serves as Quality Management Representative for the ISO 13485 QMS. You will work closely with factories, suppliers, customers and the APAC Regulatory Team.

Main 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.

Main Requirements:

• 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, specifications, 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.

What’s in it for you

In EssilorLuxottica, you are not defined just by your job title. Each career adventure is unique, but have a glimpse of the benefits and perks you can have by choosing us.

• Gain access to countless opportunities for growth - whether horizontally, vertically, or internationally - within a globally recognized leader that has a strong presence worldwide and covers every step of the value creation process (from R&D to Manufacturing, from Distribution to Stores, and everything in between).
• Join the Employee Shareholding Program to share in the Company’s success and directly benefit from EssilorLuxottica’s growth.
• Possibility of flexible ways of working and entitlement to a set number of paid days off each year to relax, recharge, spend time with family and pursue personal interests.
• Enjoy team-building events and recreational activities organized by our volunteer-based ‘Happiness Committee’ in Singapore.
• Opportunity to volunteer with the OneSight EssilorLuxottica Foundation and be an active part of our mission to improve lives by improving sight.
• Medical benefits including health insurance coverage for hospital & surgical, outpatient - general practitioner and specialist, TCM, dental, and mental wellbeing.

Our recruitment process may vary; If you are selected, you will be contacted by our recruiters to guide you through the specific steps for your application.

Our Diversity, Equity and Inclusion commitment

We are committed to creating an inclusive environment for all employees. We celebrate diversity and provide equal opportunities to all, regardless of race, gender, ethnicity, religion, disability, sexual orientation, or any other characteristic that makes us unique.