Job Description

• To work closely with regional and global RAs and speed up the preparations to planned registration projects;

• To manage and track Registration Cycle time performance for medical device and VC business in APAC region;

   
• To understand Asia Pacific regulatory environment and registration requirements;
• Support APAC markets: Including Korea, Japan, China, Taiwan HK, India, ASEAN and ANZ.
• Generate and maintain the SKU list marketed or approved in APAC region;
• To be Regulatory Liaison and support to assure the regulatory compliance.
• Provide consultations and supports to cross functions;
• Monitor country registration process and assure country RAs have the sufficient documentation supports.
• Assure regional and local regulatory compliance.

 EXPERIENCE               

• Bachelor’s degree in an appropriate discipline, plus 3 to 5 years regional RA experiences / Master’s Degree with 2 to 3 years regional RA experiences.
• Good communication skill to interact with internal Client teams and manufacturing site personnel in a professional manner
• Self -motivated to demonstrate good project management and organizational skills
• Solid-experiences with Multi-National Companies in Class I/II/III Medical Devices field
• Must be familiar with APAC Regulatory environment with good understanding of registration, labeling regulations and documentation controls
• Resourceful, flexible and capable of prioritizing projects, meeting deadlines, and working well under pressure
• Strong interpersonal, writing and verbal communication skills required
• Good written spoken and written English ability
• PC skills including spreadsheet, project management, database management are required

We offer competitive salary to the successful candidate. Interested candidates please send by mail or email your resume together with salary expectation to click "Apply Now".