Job Description

THE OPPORTUNITY

A reputable Medical Devices Company is seeking a highly motivated and talented Regional Regulatory Affairs Executive to join their team. In this role, you will be responsible for developing and implementing regulatory strategies and processes, ensuring timely product registration, life cycle management, and post-market activities. The successful candidate should possess exceptional negotiation and facilitation skills, as well as the ability to communicate effectively and promote productive discussions and collaborations across various departments. Strong time and project management skills, coupled with a keen eye for detail, are also highly valued in this role.

RESPONSIBILITIES

• Develop solutions to regulatory issues during pre-market activities and establish partnerships for effective implementation and resolution.
• Identify potential market opportunities by prioritizing product registration and reducing risks associated with regulatory approval.
• Facilitate communication and coordination between global and HQ regulatory affairs teams, as well as manufacturing sites, to ensure successful implementation of strategic plans.
• Drive regulatory affairs and quality assurance activities to ensure timely registration of products and life cycle management, while minimizing risks associated with post-marketing surveillance.
• Keep up-to-date with changes in regulatory requirements in relevant countries by monitoring relevant regulatory changes.
• Create regulatory and labeling plans to ensure consistency and provide guidance during market introduction projects.
• Provide training and knowledge sharing sessions to associates and distributors to ensure compliance with local regulations.
• Monitor the regulatory competencies of distributors and provide effective solutions for quality regulatory affairs work, while maintaining compliance with local requirements and driving business growth.

EDUCATION AND EXPERIENCE NECESSARY

• A science degree related to the pharmaceutical, life sciences, or biomedical engineering fields is required.
• At least 3 years of experience in regulatory affairs, specifically in handling product registration and license maintenance for medical devices.
• Comprehensive understanding of regulatory practices, particularly in the APAC/ASEAN region.

If you are a highly motivated and talented individual looking to advance your regulatory affairs career, please submit your most recent CV for consideration. i look forward to connecting with you! Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502