Quality and Regulatory Affairs Manager

We are seeking a Quality and Regulatory Affairs Manager to direct activities to ensure compliance with local regulations in Australia, New Zealand, South East Asia, Taiwan, and India Subcontinent areas. The role involves initiating, developing, and implementing regulatory strategies, providing regulatory authorities with documentation, and establishing relationships with external partners, regulators, and opinion formers.

Requirements

• Bachelor’s degree in Engineering, Science, or equivalent qualification
• Minimum of 5 years of experience in Regulatory Affairs and Quality Assurance within the medical device industry
• Strong knowledge of regulatory requirements across multiple regions, including the US, EU, Hong Kong, Southeast Asia, Taiwan, Australia, New Zealand, and the Indian subcontinent
• Proven experience with product registration processes and regulatory submissions across these regions
• Excellent attention to detail, strong analytical skills, and the ability to manage multiple regulatory projects effectively