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The Sartorius Group is a leading international partner of life science research and the biopharmaceutical industry. Our technologies help making the development and production of new drugs faster and more efficient, so that more people have access to better medicine. As one of the fastest-growing global life science companies, we are looking for people who share our ambition and want to make a contribution in a vibrant environment.


Aufgaben

We are currently seeking a Product Compliance Expert - Systems in our division Regulatory Compliance based in our location in Guxhagen/Germany, Sartorius Stedim Systems GmbH. In this position you will be responsible for ensuring and executing the product regulatory compliance of Instruments and Systems during development and life cycle management (product maintenance / changes) for launch readiness and regulatory compliance. You will organize regulatory information for the assigned countries/regions, oversee required tests, studies and analysis/risk assessments, track and control submissions and provide guidance and advice to internal stakeholder.

  • You will manage the activities of product compliance of assigned projects/products within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
  • You will provide product regulatory compliance input to strategic decision making, including review, prioritization, risk assessment and external communications
  • You will support the development and deployment of global policies and standards
  • You will manage test studies and gap assessments as well as successful submissions and approval of applications
  • You will plan, undertake and oversee regulatory inspections and liaise and negotiate with certification authorities
  • You will provide advice about regulations to project team members and will review and report overall quality status
  • You will keep up-to-date with changes in regulatory legislation and guidelines


Profil

What will convince us

  • Bachelor´s or Master's degree in science within a relevant scientific discipline required
  • Several years relevant experience within the Regulatory Affairs discipline and deep knowledge of the relevant Regulatory requirements
  • Thorough understanding and demonstrated ability to apply Regulatory guidelines/regulations
  • Experienced in developing innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources
  • Proven analytical skill and technical/scientific competence
  • Attention to details and ability to appropriately assess risks
  • Excellent communication skills, with ability to influence others and negotiate successful outcomes
  • Proactive, pragmatic, quick learner and independent worker able to effectively multi-task in a strongly growing organization
  • Proven ability to effectively work collaboratively in cross functional teams
  • Excellent written and verbal communication skills and fluency in English

Wir bieten

Our ambition is to simplify progress in life science research and the biopharmaceutical industry to help translate scientific findings into new therapeutics faster and more efficiently. So that more people can obtain access to better medicine. More than 11,000 employees at more than 60 production and sales locations worldwide are committed to this vision. And together, we have grown strongly over the past years. Do you also want to contribute to our vision? Grow with us and benefit from working with a Global Player that has kept its familiar atmosphere:

  • Opportunity for international career development: a global network offering seminars and training sessions, expert and manager career paths
  • Open and highly collaborative culture: mutual support within teams and working as equals, team spirit and international collaboration
  • Work-life balance: Working from home at many sites
  • Intelligent working environment: working in smart buildings with the latest technology and equipment
  • Ambitious goals: Sartorius plans to double its sales revenue approximately every five years and expects to grow its global team to approximately 15,000 people in 2025