Job Description

Position: Senior Regulatory Affairs Specialist Company Profile: Medical Devices MNC Region of work: ASEAN Your role in this position will involve the development and implementation of streamlined regulatory strategies and processes. These will be focused on ensuring the timely registration of products, efficient management throughout their life cycle, and effective oversight of post-market activities. The preferred candidate must have outstanding negotiation and facilitation skills, along with the capacity to communicate effectively and encourage productive discussions and collaborations across diverse departments. This role highly values strong time and project management abilities, as well as meticulous attention to detail.

Job Responsibilities:

• Develop solutions to regulatory pre-market activity issues
• Facilitate communication and coordination among global, HQ RA, and manufacturing sites\' RA
• Ensure distributor\'s regulatory competencies meet quality standards
• Cultivate a culture of regulatory excellence throughout the Company
• Prioritize product registration to identify potential market opportunities and reduce regulatory approval risks
• Train Company associates and distributors on local regulations and ensure compliance
• Maintain compliance with local requirements while supporting business growth
• Drive RA/QA activities to ensure timely product registration and life cycle management
• Develop consistent regulatory and labeling plans for new products
• Monitor regulatory changes to maintain up-to-date knowledge of requirements

Job Requirements:

• Bachelor\'s degree (e.g. pharmaceutical, life sciences, or biomedical engineering fields)
• 5 years of experience in regulatory affairs, preferably in the medical devices industry
• Experience in Quality Assurance is an added advantage
• In-depth knowledge of regulatory practices in the Asia region

If you\'re looking to advance your regulatory affairs career, please submit your most recent CV for consideration, and we will contact you for a confidential discussion on this excellent opportunity. Principal Consultant: Cheong Yee Yin | Registration Number: R22108633 | EA License Number: 17C8502