Key Responsibilities:

• Plan, direct, and monitor regulatory affairs activities so that the Company has the permits, licenses, certificates, authorizations, and other approvals it needs to conduct its current and future business activities and sell and distribute the goods and services. Activities include:
  • Facilitate the preparations of regulatory documents or submissions for local and/or overseas projects
  • Oversee the application process so that organization submits a full and accurate application.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Generate, review, follow up on Product Registration applications, submissions and file updates.

• Liaise with Sales and Marketing teams to understand their short to medium business goals to develop plans, cost estimates, and schedules for acquiring the necessary permits and other approvals.
• Keep abreast of regulatory and industry developments and advise Management on the potential impact of current and future regulations on the Company's operations.
• Establish and maintain positive relationships with government agencies and other regulatory authorities.
• Manage relationships with various partners' regulatory function stakeholders: product owners, head office, partners, external consultants.
• Review and prepare legal agreements in consultation with legal counsel or external consultants and manage these relationships to ensure the organization's interests are well-represented.
• Maintain current knowledge base of existing and emerging regulations, standards, guidance documents
• Generate, review and maintain Standard Operating Procedures for Product Registration, License Applications/renewals, etc.
• Plan, lead and maintain GDPMDS program as the Management Representative to meet with QMS qualifications.
• Ad-hoc as assigned

Requirements

• Excellent verbal and written communication skills
• Experience leading GDPMDS and possess knowledge of Medical Device Regulations
• Self-motivated and able to work independently with minimal supervision
• Strong organizational skills, quality orientation and high attentive to details
• Analytical skills to recognize recurring issues and causes to reach a solution
• Proficient in Microsoft 365

Song Zhao Hui EA License No. 02C3423 Personnel Registration No. R1761205

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