Regulatory Affairs Executive

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.
• 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.
• Ensure compliance with regulations, industry and company guidelines and that the regulatory affairs activities are conducted accurately, ethically.
• Prepare, 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.
• 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.
• Support compliance activities such as implementing and managing Company’s compliance program.
• Ad-hoc as assigned

Requirements

• Excellent verbal and written communication skills
• Experience leading GDPMDS and possess knowledge of local and APAC 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