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Regulatory Affairs Specialist (w/m)

  • GE Healthcare
  • Experienced
  • Posted 11/21/2017 3:49:02 AM
  • 3028080
  • Job Function: Quality
  • Business Segment: Healthcare Quality
Location(s): Austria; Pasching

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.

Essential Responsibilities:

  • Maintains records on legislation, regulations and
  • Responds
    to RA information requests
  • Conduct or assist quality on investigations related to
    regulatory requirements
  • Manage
    documentation around import/export requirements
  • Conducts research on submission requirements and options
  • Coordinates and assists in the preparation of submission
    packages for
    regulatory agencies as required and communicate any
    license approvals
  • Supports regulatory inspections as

  • 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.

Locations: Austria; Pasching

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.

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