Medical Device, Quality/Risk Management, Regulatory Compliance, US Regulatory Affairs
If you are interested in this role, please go to www.gecareers.com, requisition #3176224
Role Summary:This position provides strategic regulatory direction to the business regarding regulatory requirements for product launch, submissions and postmarket compliance. He / she leads a team of regulatory professionals in preparing regulatory strategies, premarket submissions, postmarket reporting, regulatory intelligence, regulatory requirements flow-down and postmarket compliance (e.g. advertising / promotion, etc.), as applicable
1. Provides high quality, regulatory advice and is seen as a valued strategic partner to the business he / she supports
2. Leads a team of regulatory professionals in a country, region or modality (global) in execution of regulatory affairs tasks in support of the business
3. Ensures that regulatory requirements for countries / regions are accurately captured and documented in global tools.
4. Ensures the inclusion of applicable regulatory requirements in product development for target countries 5. Prepares regulatory submissions by working across the regulatory organization and cross functionally with other functions such as Engineering and submits premarket submissions to regulatory authorities, as per business timelines
6. Prepares and files regulatory renewal / extension applications to ensure continued market access, per business direction
7. Assesses changes in existing products to and determines the need for new / revised licenses or registrations.
8. Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
9. Contributes to writing and editing technical documents
10. Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions
11. Understands and applies regulatory requirements and their impacts for submissions
12. Ensures compliance with pre- and post-market product approval requirements
13. Supports regulatory inspections as required.
14. Assesses adverse events and field actions for reportability to regulatory authorities and prepares and submits reportable events and recalls in a timely manner to regulatory authorities, as per country regulations.
15. Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager
16. Supports and encourages a collaborative, open and team based culture across his / her organization and the larger Regulatory Affairs organization
17. Is an active member of external industry trade associations and/or standards organization and/or other relevant external groups to help shape regulatory requirements 18. Interacts with and represents GEHC in interactions with regulatory agencies
1. Bachelor's Degree or a minimum of 10 years work experience.
2. 5 years Regulatory Affairs / Quality Assurance experience
3. A minimum of 5 years' experience in the medical device or pharmaceutical industry
5.Minimum of 1 year experience of regulatory project management and regulatory agency interactions
6. Experience of management of regulatory projects in global regulatory organizationsâ€¢ Where required by law the Technical Responsible will meet required qualifications in terms of education, certifications and experience (for example, Pharmacist in Brazil).
7. Experience of working globally and across different cultures
8.Ability to communicate effectively in English (both written and verbal).
9. Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation and database applications
Desired Characteristics:1. Minimum of 3 years supervisory/management experience is preferred
2. Advanced degree in scientific, technology or regulatory affairs disciplines
3. Regulatory Affairs Certification (RAPS)
4. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GEHC regulatory strategies.
5. Third party management and vendor selection experience â€¢ Strong team leadership skills, facilitates teamwork, proven ability to lead and inspire6. Assertive and willing to make decisions
7. Ability to juggle and prioritize multiple competing priorities and complete tasks on-time
8. Ability to assign clear priorities 9. Tenacious and delivery focused â€¢ Ability to make sound business judgments
Telecommuting is allowed.
Internal Number: 3176224
About GE Healthcare
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 an Equal 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.