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.
Role Summary: The Regulatory Affairs Director is responsible for leading the overall Regulatory Affairs strategy and direction within the assigned area of responsibility (technical standards, laws and regulations, regulatory programs, etc). He/she may lead a team of direct reports to deliver a world-class regulatory service to the business by creating and supporting a regulatory compliant culture, and provides advice and counsel to business managers and Quality & Regulatory personnel.
Essential Responsibilities: • Scan the external environment and work with external associations & global regulatory bodies, proactively adapt regulatory strategies, and influence change within areas of responsibility. • Identify global regulatory trends & their implications for GE Healthcare, taking into consideration the impact on business decisions • Analyze & communicate proposed, new or changing requirements and standards, & lead teams to develop strategies, programs and processes to meet business objectives and ensure compliance with regulatory requirements • Communicate with regulatory authorities within areas of responsibility. • Evaluate performance metrics to identify program weaknesses & drive improvements in procedures or oversight. • Educate, train, advise & coach company professionals to ensure compliance with RA requirements. • Work across GEHC to ensure a consistent approach to regulations is adopted throughout the business within areas of responsibility. • Lead & support continuous improvement activities with regard to areas of responsibility. • Recruit, mentor, coach and train direct and indirect reports on activities within area of responsibility
Qualifications/Requirements: 1. Bachelor’s Degree & minimum of 10 years experience in the medical device or pharmaceutical industry or medical product regulatory agencies; OR minimum of 14 years progressive regulatory affairs experience in medical device or pharmaceutical industry or medical product regulatory agencies, including knowledge & experience applying drug or device laws & regulations for product registration, adverse event reporting, & recalls. 2. At least 2 years leadership experience, including training and coaching of team members 3. Demonstrated ability to lead cross-functional, cross-business teams. 4. Demonstrated knowledge of regulatory issues and experience interfacing with local & internationals regulatory bodies, such as FDA, European competent authorities & notified bodies, Health Canada, SFDA, KFDA, MHLW, etc. 5. Ability to prioritize, plan, delegate and evaluate deliverables to established strategic goals. 6. Demonstrated experience operating in a highly regulated environment; Proven application of analytical skills in a regulatory environment 7. Strong problem solving and negotiation skills with the ability to develop and implement complex influencing and negotiating strategies that demonstrate political awareness 8. Ability to work well independently and in a team setting. 9. 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. 10. Ability to influence and make recommendations at all levels of the company 11. Experience using spreadsheet and presentation software 12. Must be willing to travel up to 15% of time
Desired Characteristics: 1. Advanced degree in scientific, technology or legal disciplines. 2. Regulatory Affairs Certification (RAPS). 3. Knowledge of Quality Management Systems 4. Experience working across cultures/countries/sites 5. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment. 6. Demonstrated ability to drive change, challenge the status quo and champion new activities, stimulating others to change and manage implementation effectively. 7. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.
We are in the process of transitioning to an improved job application system and in the interim we are operating with two systems. Have your Job ID ready (from the email you received when you applied) to log in and check your application status.
Click the appropriate button. If you don't know your job ID, you can still check your status: use both buttons.