Regulatory Affairs Specialist
- GE Healthcare
- Posted 2/1/2017 12:26:37 PM
- Job Function: Quality
- Business Segment: Healthcare Quality
Location(s): China; JiangSu; Wuxi
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
This position works within a team of Regulatory Affairs professionals to ensure GEHC establishes best practices in the area of pre- and post-market regulations, submissions and new product development.
1. Maintains records on legislation, regulations and guidelines 2. Investigates regulatory history of similar products to assess approval implications 3. Conducts research on submission requirements and options 4. Assists in monitoring and reporting project timelines 5. Responds to RA information requests 6. Communicates license approvals when received. 7. Organizes materials from preclinical and clinical studies for review and assist in review process 8. Coordinates and assists in the preparation of submission packages for regulatory agencies 9. Assists in the review of advertising and promotional items 10. Supports regulatory inspections as required 11. Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
1. Bachelor's Degree or a minimum of 3 years work experience. 2. Ability to communicate effectively in English (both written and oral). 3. Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications. Quality Specific Goals: 1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. 2. Complete all planned Quality & Compliance training within the defined deadlines. 3. Identify and report any quality or compliance concerns and take immediate corrective action as required
1. Minimum of 1 year experience in a regulated industry is preferred 2. Advanced degree in scientific, technology or legal disciplines 3. Statistics education and or training 4. Ability to work independently in fast-paced environment with little supervision. 5. Ability to adapt to constant change and influence positive change effectively. 6. Team-oriented and responsive to customer needs. 7. Attention to Detail and Results-Oriented. 8. Ability to understand technical documentation and execute associated procedures
Locations: China; JiangSu; Wuxi