General Electric Regulatory Affairs Leader/Specialist (AI Software Product) in Beijing, China
Essential Responsibilities:• Provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements
• Manage medical device registration whole processes from project kick-off to product launch; To actively contact with external parties such as testing lab, government agency to accelerate the registration processes
• Works with a cross functional team closely to ensure the registration files quality and completion on time
• Assesses changes in existing products to and determines the need for new / revised licenses or registrations
• Develops plan for timely submission of extension registrations per business plan, to ensure continued product supply
• Understands and applies regulatory requirements and their impacts for submissions
• Ensures compliance with pre- and post-market product approval requirements；Supports regulatory inspections as required
Qualifications/Requirements:• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
• Bachelor’s degree or above major in biotechnology and software related subject;
• English communication in speaking, listening and writing;
• Good communication skills;
Desired Characteristics:• Leader: 3+ years working experience as regulatory affairs or software engineer in medical device company is preferred.
• Ability to work independently in fast-paced environment with little supervision.
• Ability to adapt to constant change and influence positive change effectively.
• Team-oriented and responsive to customer needs.
• Attention to Detail and Results-Oriented.
About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.comAdditional Locations:China;BeiJing;Beijing;