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Director Regulatory Affairs

  • Job type: Permanent
  • Location: Bangkok Province
  • Salary: Negotiable
  • Job reference: 533380/003_1528885906
  • Sector: EPM Scientific, Regulatory
  • Date posted: 13/06/2018

Regulatory Affairs Director

This Regulatory Affairs Director will lead the Regulatory department and oversee the building out of the regulatory affairs team, working with a multifunctional project team, currently including 12 regulatory affairs team members. The Regulatory Affairs Director will coordinate, implement and execute all regulatory activities and strategies for the medical devices.

Company Overview

They are a growing, innovation company looking for a talented Regulatory Director to provide leadership, customer relations and team motivations for all regulatory activities. They provide a market focused approach with a tailored approach dominating the market in High Technology devices provide their customers with the most innovative engineering services and world-class manufacturing. There standard of excellence not only applies for their operations but to the way they treat one another in the organisation. They are looking for a visionary leader in this challenging and exciting position. Are you ready to make an impact within the organisation?

Responsibilities:

  • Develop and implement Regulatory Strategies for assigned projects/products
  • Coordinate the regulatory team in harmony with the software development team and the image analysis team to define documentation strategy
  • Provide expertise in applicable regulations in order to identify and suggest potential strategies that can be used to address the gaps
  • Direct regulatory aspects of projects/products, including the preparation and submission of correspondence and applications to regulatory agencies
  • Support implementation of device change in order to assess regulatory implications

Requirements:

  • Bachelor's degree in physical/biological sciences or engineering preferred
  • Expertise in standards and regulations for medical devices as ISO 13485, IEC 62304, IEC 62366, ISO14971, CFR Part 820
  • Experience leading people and projects
  • Experience with Regulatory Affairs for medical device AND/OR IVD software
  • Strong written and verbal English communication skills

Package:

  • Competitive benefits and great personal development opportunities
  • Work in the city centre Bangkok
  • Great atmosphere within a vibrant international team
  • A modern and creative working environment
  • Insight into cutting-edge technologies for the successful development of cancer therapies

If you are interested in being a key player in the company's growth then then please apply to Bethan Williams on +44203758858

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