GE Healthcare
AI Documentation Leader(m/w/x)
Full-timeOn-siteExperienced
Zipf
from 70,000 / year
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GEGE Healthcare
Regulatory Affairs Leader - Ultrasound Probes(m/w/x)
Zipf
Full-timeOn-siteExperienced
Nejo AI Summary
Leading global regulatory strategy for Ultrasound Probe programs, coordinating global submissions with design and manufacturing teams. Proven experience in a regulated field with advanced Quality & Regulatory Affairs understanding required. Direct impact on global market access for medical ultrasound technology.
Requirements
- Advanced understanding of Quality & Regulatory Affairs
- Proven experience in a regulated field
- Bachelor's degree in biomedical engineering, regulatory affairs, or equivalent
- Strong oral and written communication skills
- Demonstrated problem analysis and resolution ability
- Ability to document, plan, market, and execute programs
- Established project management skills
- Strong English communication skills (written and oral)
Tasks
- Collaborate with design, manufacturing, and global regulatory teams.
- Provide regulatory strategy and direction to the business.
- Work closely with global healthcare regulatory bodies.
- Lead strategic regulatory affairs for Ultrasound Probe programs.
- Support global registration planning, submissions, and audits.
- Implement programs across cross-functional teams.
- Communicate program status to leadership.
- Ensure compliance of premarket submissions and registrations.
- Ensure post-market compliance.
- Develop regulatory strategies considering requirements, claims, and dependencies.
- Assess product changes for new/revised licenses and registrations.
- Review and approve advertising/promotion material for compliance.
- Write and edit technical documents.
- Research and analyze background information for submissions.
- Integrate and organize background information for submissions.
- Apply regulatory requirements to submissions and compliance.
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of GE Healthcare and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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GEGE Healthcare
Regulatory Affairs Leader - Ultrasound Probes(m/w/x)
Zipf
Full-timeOn-siteExperienced
Nejo AI Summary
Leading global regulatory strategy for Ultrasound Probe programs, coordinating global submissions with design and manufacturing teams. Proven experience in a regulated field with advanced Quality & Regulatory Affairs understanding required. Direct impact on global market access for medical ultrasound technology.
Requirements
- Advanced understanding of Quality & Regulatory Affairs
- Proven experience in a regulated field
- Bachelor's degree in biomedical engineering, regulatory affairs, or equivalent
- Strong oral and written communication skills
- Demonstrated problem analysis and resolution ability
- Ability to document, plan, market, and execute programs
- Established project management skills
- Strong English communication skills (written and oral)
Tasks
- Collaborate with design, manufacturing, and global regulatory teams.
- Provide regulatory strategy and direction to the business.
- Work closely with global healthcare regulatory bodies.
- Lead strategic regulatory affairs for Ultrasound Probe programs.
- Support global registration planning, submissions, and audits.
- Implement programs across cross-functional teams.
- Communicate program status to leadership.
- Ensure compliance of premarket submissions and registrations.
- Ensure post-market compliance.
- Develop regulatory strategies considering requirements, claims, and dependencies.
- Assess product changes for new/revised licenses and registrations.
- Review and approve advertising/promotion material for compliance.
- Write and edit technical documents.
- Research and analyze background information for submissions.
- Integrate and organize background information for submissions.
- Apply regulatory requirements to submissions and compliance.
Work Experience
- approx. 1 - 4 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of GE Healthcare and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
GE Healthcare
Industry
Healthcare
Description
Das Unternehmen ist ein global führender Innovator für Medizintechnik und digitale Lösungen mit mehr als 100 Jahren Erfahrung im Gesundheitswesen.
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