Job Responsibilities:
• Responsible for all regulatory affairs, regulatory compliance activities and submission of registration of medical device of the company.
• Gain and maintain optimal regulatory approvals in a timely manner and in compliance with relevant regulations
• Review and update information, labels and other documentation as required for regulatory compliance
• Maintain and track the import licenses’ validity of all marketed products 5. Build constructive relationships with local regulatory representatives and local health authorities, as required and maintain an awareness of new legislation, policies and guidelines of local health authorities impacting the company
• Responsible in reporting to local health authorities regarding Field and Safety Corrective Action and Adverse Event and maintain its database
• Provide regulatory inputs and support for marketing plans, product registration and variations to the marketed products
• Safe keeps confidential records
• Maintain all regulatory databases and report to regional RA supervisor in a timely manner
Requirements:
• Degree in Science, Biotechnology or Pharmacy
• Minimum 1-year relevant working experience
• Process keen interest in regulatory work
• Pleasant, positive, meticulous and independent worker who is able to multi task Computer literacy
• Able to handle administrative duties with good document organization skills.