· Responsible for preparation and submission of all documents and other required needs to Local Health Authority (Myanmar FDA) to get import recommendation approval of Medical Devices.
· Also maintaining the relationship with suppliers (Clients) to get the required documents and other needs and also with internal teams/departments for smooth operation of RA procedures.
· Keep update with FDA new announcements/ changes in regulatory laws & guidelines and share information to internal team and principal side if required.
· Send regular report to principal side as required
· Enable to handle advance/expense claim process with Finance team for departments’ expense. (if needed).
· Prefer Bachelor of Pharmacy
· Master/Bachelor in Scientific
· At least one to two-year experiences in regulatory affairs field
· Strong negotiation, communication, organization, problem solving, team work and time management skills
· IT skills
· Good in English 4 skills
· Good knowledge in regulatory regulations and guidelines
· Background knowledge in regulatory practice and regulation of ASEAN and other countries
· Experience in medical equipment, healthcare products and pharmaceutical products industry
· Experience in working with government authorities
· Ability to multitask and under limited supervision
· Ability to travel if required