SEA QARA Manager

Position: SEA QARA 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 Affrair 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