Regulatory Affairs

　　Date: Feb 7, 2024

　　Brand: Corporate

　　Location:

　　Khet Patumwan, Bangkok, TH

　　Requisition ID: 832142

　　Position: [[cust_EmpStatus]]

　　We are EssilorLuxottica, a global leader in the design, manufacture and distribution of ophthalmic lenses, frames and sunglasses. The Company brings together the complementary expertise of two industry pioneers, one in advanced lens technologies and the other in the craftsmanship of iconic eyewear, to create a vertically integrated business that is uniquely positioned to address the world’s evolving vision needs and the global demand of a growing eyewear industry.

　　With over 180,000 dedicated employees in 150 countries driving our iconic brands, our people are creative, entrepreneurial and celebrated for their unique perspectives and individuality. Committed to vision, we enable people to “see more and be more” thanks to our innovative designs and lens technologies, exceptional quality and cutting-edge processing methods. Every day we impact the lives of millions by changing the way people see the world.

　　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. Greasing the wheels behind the scenes, our people in Operations are the backbone of our Company.

　　The Trade Compliance & Regulatory Affairs (RA) function is part of EssilorLuxottica SEAK, India & Japan Legal Department.

　　Nice to know:

　　Providing support to group entities in addressing their regulatory priorities in areas of Medical Device regulations, Investment incentives, International Trade and other Regulatory matters.

　　Securing Investment Incentives for new & existing projects,

　　Providing support & guidance to the group companies in the region on regulatory matters

　　Your day at EssilorLuxottica:

　　The Regulatory Affairs Officer supports the Department in ensuring compliance with Medical Device regulations and handling other Regulatory matters for group entities in the region.

　　He or she takes the lead on Regulatory matters and projects in following areas :

　　Medical Device Control

　　Securing Establishment Licenses, including compliance with pre & post license conditions

　　Product Registrations/Licenses, including compliance with pre & post-license conditions (including reporting (statutory, AE, DD etc.), labeling, Post Market Surveillance, marketing claims).

　　Regulatory Audit of group entities and Ensuring Regulatory Compliance for existing entities and projects, including submission of annual reports to the Medical Device Regulatory authorities in the country.

　　Investment Incentives

　　Securing approvals for new projects

　　Ensuring Compliance with Investment Promotion conditions.

　　External and internal reporting of Tax savings

　　Handling other regulatory and compliance related matters as & when required

　　Must have:

　　Bachelors / Master degree in Legal, Commercial, Lifesciences field.

　　4-6 yrs experience in Legal and/or Regulatory Affairs function in a Medical Device / Pharmaceutical Company.

　　Good understanding of Regulatory requirements and Medical Device standards in the region such as ISO 13485, MDR, FDA regulations etc.

　　Strong knowledge, including hands on experience in preparation and submission of License applications, Product registration dossiers to the Regulatory authorities.

　　Excellent communication and presentation skills with ability to collaborate with cross functional teams.

　　Good Project management skills for managing projects focused on Regulatory Compliance, Process improvement, etc.

　　Aptitude towards developing networks and lobbying with external agencies (incl. FDA, BOI & other govt. departments.)

　　Fluency in English and Thai (Written & spoken), knowledge of additional South East Asian language would be an advantage.

　　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.

　　Upon request and consistent with applicable laws, EssilorLuxottica will provide reasonable accommodations to individuals with disabilities who need assistance in the application and hiring process.  To request a reasonable accommodation, please call the Luxottica Ethics Compliance Hotline at 1-888-887-3348 (be sure to provide your name and contact information so that we may follow up in a timely manner) or email [email protected].

　　We are an Equal Opportunity Employer.  All qualified applicants will receive consideration for employment without regard to race, color, gender, national origin, social origin, social condition, being perceived as a victim of domestic violence, sexual aggression or stalking, religion, age, disability, sexual orientation, gender identity or expression, citizenship, ancestry, veteran or military status, marital status, pregnancy (including unlawful discrimination on the basis of a legally protected pregnancy or maternity leave), genetic information or any other characteristics protected by law. Native Americans in the US receive preference in accordance with Tribal Law.

　　Job Segment: Medical Device, Supply Chain, Supply, Business Process, Ophthalmic, Healthcare, Operations, Management