Regulatory Affairs Leader

Job description

3079876
City

Waukesha
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Quality
Function

Quality
Country/Territory

United States
U.S. State, China or Canada Provinces

Wisconsin
Postal Code

53188-1696
Role Summary/Purpose

This position provides subject matter guidance. He/she works within a team of Regulatory Affairs professionals to ensure GEHC establishes best practices in compliance with regulatory requirements. The Regulatory Affairs Leader will be involved with regulatory activities in the areas such as premarket submissions, post-market reporting, regulatory intelligence, regulatory requirements flow-down advertising and promotion review, product labeling compliance, etc.
Essential Responsibilities

1. Provides regulatory input to ensure compliance to regulatory requirements for target markets 2. Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements 3.Supports
the regulatory requirements flow-down by working on regulatory impact
assessments and ensuring communication through the applicable channels. 4. Owns QMS
and Regulatory Functional documents ensuring timely and accurate updates of such
documents; 5. Develops
and implements guidance to govern the Regulatory Functional documents to ensure
consistency during QMS refresh cycles as well as Ad Hoc updates; 6. Maintains
the RA training plan in partnership with QA and other cross functional areas;
ensures that trainings are properly assigned to RA employees and changes driven
by QMS/RA Functional documents updates are made; additionally, pulls monthly
metrics report with RA training performance 7. Owns the
Central RA Support Central assuring that documents, links and all RA related information
are current and properly displayed on the website 8.
Understands regulatory requirements and their impact for product submissions 9. Supports
regulatory inspections as required 10. Be a
subject matter expert on RA tool providing support to RA users as well as being
one of the points of contact for IT team on enhancements and future
developments 11. Performs
a broad variety of tasks in support of projects, including the RA Digitization
initiative, and process simplification as assigned by the departmental manager

Qualifications/Requirements

1. Bachelor's Degree or a minimum of 4 years work experience. 2. Minimum of 1 year experience working in a regulated industry 3. Where required by law the Technical Responsible will meet required qualifications in terms of education, certifications and experience (for example, Pharmacist in Brazil) 4.Ability to communicate effectively in English (both written and oral). 5. Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
Desired Characteristics

1. Minimum of 3 years experience medical device regulatory affairs. 2. Advanced degree in scientific, technology or legal disciplines 3. Regulatory Affairs Certification (RAPS) 4. Statistics education and or training 5. Ability to work independently in fast-paced environment with little supervision. 6. Ability to adapt to constant change and influence positive change effectively. 7. Team-oriented and responsive to customer needs. 8. Attention to Detail and Results-Oriented. 9. Ability to understand technical documentation and execute associated procedures
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 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.
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 drug screen.