GE é a maior empresa Digital Industrial do mundo, dedicada a transformar a indústria com máquinas e soluções conectadas a softwares que garantem previsibilidade e respostas rápidas. Com seus times, tecnologias, serviços e escala, a GE busca proporcionar melhores resultados para seus clientes, por falar como ninguém a linguagem da indústria.
Role Summary: The Regulatory Affairs (RA) Leader – Product provides subject matter expertise. He/she works within a team of Regulatory Affairs professionals to ensure GEHC establishes best practices in the area of premarket regulatory and new product development.
Essential Responsibilities: • Work closely with regulatory, engineering, marketing, legal, and other professionals across the company to develop & implement company-wide programs and processes for regulatory affairs compliance within areas of responsibility. • Identify regulatory trends and their implications for GE Healthcare; Develop & implement effective regulatory strategies to meet business objectives. • File / maintain regulatory deliverables • Actively participate as team member on all assigned new product introductions/transfer. • Create regulatory project plan to ensure all requirements are met for product transfer/ development; • Work with relevant personnel to ensure appropriate, timely input is provided for submissions. • Create and file regulatory documents; • If specific country testing is needed, support as needed. Example: INMETRO certification • Review changes in existing products to determine need for new/revised submissions or document reason for no submission; • Communicate changes in existing products to Region RA representatives for determination of the need for new/revised licenses or registrations. • Educate, train, & advise company professionals to ensure compliance with regulatory requirements; • Partner with Region RA representative for countries with license expiration requirements, to establish plan and deliverables for timely submission for renewal of license. • Identify any clinical data requirements for product licensing globally and ensure the requirements are documented in the compliance plan. • Support continuous improvement activities in the area of responsibility. • Drive improvements to overall Quality Management System documentation to provide clear flow down of regulations in areas of responsibility. • Support local regulatory authority / notified body inspections as required • Coach other RA professionals.
Qualifications/Requirements: Quality Specific Goals: • 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 • Complete all planned Quality & Compliance training within the defined deadlines • Identify and report any quality or compliance concerns and take immediate corrective action as required • Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility. • Effectively support implementation & management of current regulatory requirements within area of responsibility. • Ensure assigned regulatory documentation are accurate, complete and timely.
Required Qualifications: 1. Bachelor’s Degree (or internationally recognized equivalent) & minimum of 5 years of regulatory affairs experience in medical device or with medical product regulatory agencies, including knowledge & experience applying device laws & regulations for product registration 2. Ability to prioritize, plan & evaluate deliverables to established strategic goals. 3. Proven application of analytical skills in a regulatory environment 4. Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner. 5. Strong problem solving and negotiation skills 6. Ability to work well independently & in a team setting. 7. Prior experience using spreadsheet and presentation software.
Desired Characteristics: 1. Advanced degree in Engineering or Pharmacy. 2. Knowledge of Quality Management Systems (QMS) 3. Experience with working across cultures/countries/sites 4. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment. 5. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.
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