Manage regulatory affairs projects under his/her responsibilities agreed with RA/QA Manager and Head of division
Ensure product life cycle management and post approval change controls are done as required for the projects under his/her responsibilities.
Establish and maintain collaborative relationship with CoE GRA and internal stakeholders, as well as external stakeholders
Manage RA budget for responsible regulatory projects
Provide regular monitoring and business impact analysis of regulatory environment changes and share them with wider group as required to ensure alignment.
Provide role modeling and proper daily coaching to subordinates on the job to solve issues, facilitate RA strategies and to ensure their communication and behaviors are at optimal level as required by company
Support RA/QA mgr. to build a strong team of professionals with high level of engagement, optimal performance and in-depth job competency
Understand and implement company policy and guideline as required as people leader
Job Requirements
4 years university degree in science, life science or medical engineering
Minimum 10years relevant experience in medical device industry
Multinational company experience preferred
Experience of leading people or sub team preferred