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.
Role Summary: This position works within a team of Regulatory Affairs professionals to ensure GEHC Life Sciences establishes best practices in the area of pre- and post-market regulations, submissions and new product development for the BioProcess business.
Maintainsrecords on legislation,regulationsand guidelines
Responds to RAinformationrequests
Conduct or assist quality on investigations related to regulatory requirements
Manage documentation around import/export requirements
Conductsresearch on submission requirementsand options
Coordinatesand assistsin thepreparationofsubmission packages forregulatoryagencies as required and communicate any license approvals
Supports regulatoryinspectionsas required
Bachelor's Degree or work experience in Healthcare or strongly regulated industry (Quality or Regulatory)
Ability to work independently in fast-paced environment with little supervision
Team-oriented and responsive to customer needs
Ability to communication in a positive and professional manner with internal and external stakeholders
Assertiveness is one of your strengths
Good English and German skills (both written and oral)
Desired Characteristics: The collective agreement provides a minimum gross salary of € 2.224,09 per month/ IV first and second year. Salary depends on qualification and experience and might be higher.
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