Regulatory Affairs Leader
- GE Healthcare
- Posted 7/26/2017 5:43:57 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 provides subject matter guidance. He/she 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. Files / maintains regulatory deliverables 2. Participates as team member on all assigned new product introductions as applicable. 3. Communicates changes in existing products to applicable RA representatives for determination of the need for new/revised licenses or registrations. 4. Reviews and approves advertising and promotion material ensuring it is consistent with approved claims for regulated products. 5. Partners with applicable RA representative for countries with license expiration requirements, to establish plans and deliverables for timely submission for renewal of license. 6. Identifies any clinical data requirements for product licensing globally and ensure the requirements are documented in the compliance plan. 7. Completes specific country testing and work with Region RA, and arranges for test devices and support as needed. 8. Contributes to writing and editing technical documents 9. Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions 10. Understands and applies regulatory requirements and their impacts for submissions 11. Ensures compliance with pre- and post-market product approval requirements 12. Supports regulatory inspections as required. 13. 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 4 years work experience. 2. Minimum of 1 year experience working in a regulated industry or a Masters degree 3. Ability to communicate effectively in English (both written and oral). 4. 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 3 years experience in a regulated industry is preferred 2. Advanced degree in scientific, technology or legal disciplines 3. Regulatory Affairs Certification (RAPS) 4. Statistics education and or training 5. Ability to work independently in fast-paced environment with little supervision. 6. Ability to adapt to constant change and influence positive change effectively. 7. Team-oriented and responsive to customer needs. 8. Attention to Detail and Results-Oriented. 9. Ability to understand technical documentation and execute associated procedures
Locations: China; JiangSu; Wuxi