Our client is a global medical devices manufacturing. The working location is in Bangkok area.Job Description
Establish rapport with government authorities and drive timely approval of applications to ensure unhampered business operation and continuous business developments.
Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new or changed product launches.
Develop and implement documented regulatory end-to-end process to establish efficient and systematic work structure.
Implement applicable regulatory conditions such as but not limited to country label requirement; post notification requirements, post registration requirements and reporting requirements through engagement with internal stakeholders and functional supports to achieve full regulatory compliance.
Establish, manage, and maintain central documentation of submissions and relevant correspondence with authorities ensuring implementation of proper controls in confidential business information handling.
Ensure project data, including information used to maintain compliance and aid with submission planning, is accurately reported in databases.
The Successful Applicant
Bachelor's degree or higher in Science, Pharmacy, or related field
Prior experience working in a Regulatory Affairs role handling Medical Devices or Pharmaceuticals
Familiar with medical device standards such as ISO 13485 and FDA
Ability to lead, supervise and work independently and in teams.
Excellent English communication, independent, and proactive
What's on Offer
Excellent career path with global organisation
Competitive benefit
ContactPuvadol PulputQuote job refJN-042024-6392770Phone number+66 2 012 5071Job summary Sector Specialisation What is your area of specialisation? Location Contract Type Consultant name Puvadol Pulput Consultant phone +66 2 012 5071 Job Reference JN-042024-6392770
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