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Teamleader Regulatory Affairs

Reference No.: 4317 Tags: Jobs, Headquarters Germany, DE > Görlitz, Other, More than 2 years practical experience

Place of work: Arndtstraße 11a-b, 02826 Görlitz, DE

Are you looking for more than just a job? Something truly significant and worthwhile? Then Sysmex Partec is the right place for you. Our products are needed. By people all over the world, for a healthy life.
If this appeals to you, come and join us in the position of

Teamleader Regulatory Affairs

Your responsibilities

  • Ensure compliance with all relevant regulations in accordance with applicable laws and standards
  • Develop, implement and improve global regulatory policies, procedures and controls for the registration of our IVD - Medical Devices
  • Support with regulatory submissions and product registrations
  • Personnel and professional responsibility for Regulatory Affairs team and monitoring of team objectives
  • Ensure regulatory product compliance and correct product labeling
  • Collaborate with external service providers, regulatory agencies, and coordinate regulatory interactions and compliance activities

Your profile

  • Completed technical or scientific studies or comparable qualification
  • Professional experience in the field of regulatory affairs required
  • Leadership experience and the ambition to continuously develop employees as well as yourself
  • Deep knowledge of quality standards and regulatory requirements in the medical device industry environment
  • Strong regulatory background, strategic thinking and a strong understanding of regulatory processes and procedures as well as experience with go-to-market strategies is essential
  • Good knowledge of the MS - Office - package
  • Business fluent in English (written and spoken), good knowledge in German and basic knowledge of Japanese is an advantage
  • Distinct problem-solving and a high willingness to change and cooperate
  • Independent action and pragmatic way of thinking
  • Strong communication skills and solution-oriented way of working

We offer

  • A growing and healthy corporate group which stands for quality and innovation
  • A strong corporate culture with respect and trust as the basis for cooperation and communication
  • A challenging and multifaceted position with numerous chances to see the bigger picture and contribute to the company’s success in an innovative international environment

Did we spark your interest? Then we look forward to receiving your application with salary requirements and the earliest possible starting date.

Our Company

The highest quality of healthcare: As a multinational company Sysmex Partec has been developing, producing and selling innovative flow cytometry devices for the lab sector worldwide for 50 years. With more than 1,000 employees in Germany, we live by the philosophy of “Shaping the advancement of healthcare“ every day. 

Do you have questions?

Anne Westermeier
Phone: 03581 8746-0

Sysmex Partec GmbH, Human Resources, Arndtstraße 11a-b, 02826 Görlitz
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