Regulatory Affairs Leader – AI Software Devices

Artificial IntelligenceArtificial IntelligenceFull TimeRemoteSeniorTeam 10,001+Since 1892H1B SponsorCompany SiteLinkedIn

Location

Germany

Posted

1 day ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglish

Job Description

Regulatory Affairs Leader – AI Software Devices

GE HealthCare

• Provide regulatory leadership and strategic direction for Ultrasound regulatory AI Software programs • Support compliance of premarket submissions/registrations and post market compliance • Develop regulatory strategies to help optimize regulatory submission pathways • Utilize technical expertise and judgement to solve problems • Assess changes in existing products and determine the need for new / revised licenses or registrations • Review and approve advertising and promotion material to ensure consistency with approved claims and regulatory requirements • Contribute to writing and editing technical documents • Research, analyze, integrate and organize background information from diverse sources for regulatory submissions • Apply regulatory requirements and understand their impacts on submissions and pre- and post-market compliance.

Job Requirements

  • Proven experience working in a regulated field, especially AI software
  • Advanced practical experience in the Quality & Regulatory Affairs
  • Bachelor's degree in software engineering, regulatory affairs or equivalent
  • Strong oral and written communication skills
  • Demonstrated ability to analyze and resolve problems
  • Ability to document, plan, market, and execute programs
  • Established project management skills
  • Strong communication skills in English (both written and oral).

Benefits

  • Inclusion and diversity
  • Equal Opportunity Employer

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