SEA Quality Regulatory Manager

About the Company

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 the Essilor brand, with Varilux, Crizal, Eyezen, Stellest and Transitions, iconic brands that consumers love such as Ray-Ban, Oakley, Persol and 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, and Target Optical, and leading e-commerce platforms.

Our unique business model and relentless pursuit of operational excellence ensures that consumers everywhere have access to products. Balancing speed, efficiency and proximity, the Company manages a global supply chain with cutting-edge technology, based on centralization for frames and on a capillary network for lens finishing and prescription laboratories. In our dynamic environment, fueled by technology and innovation, our people have the space to pioneer new solutions.

Join our global community of over 200,000 dedicated employees around the world in driving the transformation of the eyewear and eyecare industry. Discover more by following us on LinkedIn!

Position: SEA Quality Regulatory Manager – EssilorLuxottica South East Asia Cluster

Responsibilities:

• Take care of Regulatory Affairs responsibilities of EssilorLuxottica South East Asia cluster for both operation and commercial
• Handle the Medical Devices or consumer electronic products Regulatory Submissions and Approvals (Product Registrations, Preparation of Technical files, experiences will be preferred for class-2 Medical Devices e.g. Instruments, Nuance and/or consumer electronic products )
• Local Labelling Compliance and Risk Management
• Act as the main point of contact for SEA, especially Thailand and global QARA communication and coordination.

Experiences:

• Regulatory Affair experiences in a medical device company and/or consumer electronics product
• Experience in implementation of QMS based on ISO 13485 or similar quality management systems
• 10 years’ experiences in manufacturing or production as well as commercial environments preferred
• Solid experience and network with Government bodies and Authorities in SEA Countries - e.g Board of Investment, FDA authorities, Customs, Industrial zones and relevant ministries

This posting is for an existing vacancy within our business. Employee pay is determined by multiple factors, including geography, experience, qualifications, skills and local minimum wage requirements. In addition, you may also be offered a competitive bonus and/or commission plan, which complements a first-class total rewards package. Benefits may include health care, retirement savings, paid time off/vacation, and various employee discounts.