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Located in Bangkok and reporting to Asia Operations Trade compliance and regulatory affairs Director and AMERA SC Director, ASEAN regulatory specialist will work in priorities on the following missions:

 

  • Ensure the regulatory CAPA management over AMERA countries with a priority upon ASEAN zone : from internal source or from post market information
  • Define and implement regulatory requirements in QMS entities
  • Promote Essilor regulatory position at ASEAN/AMERA level

 

 

Key Duties & Responsibilities

 

  •  Regulatory & QMS Training
  •  Regulatory CAPA management : Make sure regulatory events are managed with pilots & timeline
  •  Management & Follow-up of local regulatory projects (traceability, QMS …)
  • Centralize entities internal/external audits results
  •  Monitor and communicate about product manufacturing regulatory compliance (versus internal and external standards)
  •  Support  local regulatory network and promote synergies
  •  Raise issues and request support from Global regulatory affairs
  • Consolidate ASEAN common requirement based on local regulatory watch
  •  Lobbying in ASEAN common regulation using consultant or lobbying company
  •  Be the expert for the local regulation
  • Implement regulatory requirement into local QMS process
  • Keep an up to date chart on role & responsibilities
  •  

Product Regulatory manager will be in contact with following entities/departments in the different Regions/zones and Group entities: Group Regulatory & Standardization affairs, Zone Quality, R&D, Marketing, Projects, Legal, Trade, Supply chain, EHS,  Suppliers/Subcontractors, Optical Industry Associations, Notified Bodies.

 

 

Key areas:

 

  • Transversal management
  • Initiative and autonomy in a cross-functional position
  • Curious and pragmatic with self development capacity.
  • Ability to interpret technical standards, legal and regulatory documents.
  • Capacity to transfer knowledge thought trainings and tools.
  • Good interpersonal skills and business focus.
  • Experienced in Regulatory Affairs : medical device or automotive industry

 

 

 

Good knowledge of Office software, Google environment and data analysis/reporting tool