About Us: 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.
GE Healthcare provides transformational medical technologies and services to meet the demand for increased access, enhanced quality and more affordable healthcare around the world. GE works on things that matter - great people and technologies taking on tough challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery, biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps medical professionals deliver great healthcare to their patients.
Role Summary: 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.
Essential Responsibilities: Key responsibilities include: • Maintains records on legislation, regulations and guidelines • Investigates regulatory history of similar products to assess approval implications • Conducts research on submission requirements and options • Assists in monitoring and reporting project timelines • Responds to RA information requests • Communicates license approvals when received. • Organizes materials from preclinical and clinical studies for review and assist in review process • Coordinates and assists in the preparation of submission packages for regulatory agencies • Assists in the review of advertising and promotional items • Supports regulatory inspections as required • Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
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
Qualifications/Requirements: 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.
Desired Characteristics: 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
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