GE Executive - Regulatory Affairs, Imaging in Waukesha, Wisconsin
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 offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Posted Position Title
Executive - Regulatory Affairs, Imaging
Location(s) Where Opening Is Available United States
U.S. State, China or Canada Provinces
Leads the regulatory function for medical devices or pharmaceuticals within GE Healthcare, with overall responsibility for delivering a world-class regulatory service to the business and ensuring consistent, compliant best practices in regulatory processes are applied across GE Healthcare
Work closely with senior business executives (e.g. CQO, P&L CEO, Quality, Legal, Marketing, Engineering, Manufacturing, Service) to develop and implement regulatory strategies, policies and positions consistent with the business vision and global regulatory requirements; provide proactive regulatory advice, expertise & data on a global basis to guide management & drive decisions
Monitor the external landscape to formulate regulatory strategies and take into consideration the impact of business decisions; work closely with regulatory bodies globally
Continuously review and put strategies in place to improve existing processes and champion implementation of new initiatives across the GEHC regulatory function to ensure consistency, compliance and best practice
Comment on, and ensure appropriate company review of, draft legislation, regulation, and guidance affecting GE Healthcare
Share regulatory intelligence for wider dissemination and impact assessment; provide regulatory data for repository
Build global network of regulatory professionals across the company; lead regulatory colleagues across GEHC to ensure a consistent approach to regulatory authorities is adopted throughout the business
Recruit, mentor, coach and train direct and indirect reports on activities within areas of responsibility
Coach RA Leaders within each Region/P&L/Business to develop effective regulatory strategies that meet business goals
Identify, assess and manage global regulatory risk proactively
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
- J.D or Master’s Degree in Regulatory Affairs (or other related field) & minimum of 7 years experience in the medical device or pharmaceutical industry or with medical product regulatory agencies; OR Bachelor’s Degree & minimum of 12 years experience in the medical device or pharmaceutical industry or with medical product regulatory agencies; OR minimum of 16 years progressive regulatory affairs experience in medical device or pharmaceutical industry or with medical product regulatory agencies, including knowledge & experience applying drug or device laws & regulations for product registration, adverse event reporting, & recalls. 2. Minimum of 5 years management experience including hiring, training, coaching and performance management activities 3. Extensive knowledge of international regulatory requirements, including Canada, China, Europe, Japan, Korea, Latin America, & United States. 4. Demonstrated experience interfacing with local & international regulatory bodies, such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc. 5. Knowledge of Quality Management Systems 6. Strong problem solving and negotiation skills with the ability to develop and implement complex influencing and negotiating strategies that demonstrate political awareness; Ability to influence and make recommendations at all levels of the company 7. Demonstrated project management skills to establish strategic goals and to prioritize, plan, delegate & evaluate deliverables 8. Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English, tailoring communication methods to customer’s requirements. 9. Prior experience using spreadsheet and presentation software 10. Must be willing to travel up to 25% of time
Additional Eligibility Qualifications
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.
Regulatory Affairs Certification (RAPS).
Advanced degree in scientific, technology or legal
Significant experience interfacing with external regulatory agencies (e.g. FDA) on pre-market and post-market issues, to detect trends and align priorities as needed
Demonstrated experience with a new product introduction process (i.e. new product launches)
Experience working across cultures/regions/sites
Demonstrated ability to drive change, challenge the status quo and champion new activities, stimulating others to change and manage implementation effectively
Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies