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Teamleader Regulatory Affairs (w/m/d)

Sysmex-Partec GmbH • Görlitz

Bild zur Stelle Teamleader Regulatory Affairs (w/m/d)

Allgemeine Angaben

Arbeitsbereich: Führungskräfte/Management
Beschäftigungsart: Vollzeit
  • Analysieren
  • Entwickeln
  • Kontrollieren
  • Organisieren
  • Personal führen
  • Dokumentieren
Arbeitszeit: 40 Std./ Woche
Arbeitsbeginn: per sofort
Anzahl der Stellen: 1


Sysmex Partec GmbH is a globally operating diagnostics company. We are specialize in the development and production of highly sensitive flow cytometry solutions in various application areas.

Healthcare of the highest quality: As a multinational company, Sysmex Partec has been developing, producing and distributing innovative highly sensitive flow cytometry solutions in various fields of application in diagnostics, research and industry worldwide for 50 years. With approximately 200 employees, we live our company philosophy every day: "Shaping the advancement of healthcare".

At Sysmex Partec, we want to help shape the advancement of healthcare. We want to help people with our innovative products. This is the foundation of our company and the reason why we do what we do. To achieve this goal, we need people who enjoy working in an innovative work environment with their commitment to be part of a great team. What unites us all at Sysmex Partec is the pursuit of quality and appreciation for each individual: their background, their skills, their ambitions, their goals. We place great value on authenticity and that each employee can develop freely. We see this as the basis of our success.

The Sysmex Group is active worldwide with more than 9,000 employees in over 190 countries. 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 (w/m/d)

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

  • Arndtstraße 11 a-b - 02826 Görlitz

Gehalt (brutto): Keine Angaben
Lohnart: keine Angabe

Geeignete Berufe / Abschlüsse

  • Qualitätsingenieur/Qualitätsingenieurin
  • Ingenieur/Ingenieurin für Medizintechnik
  • Qualitätsmanager/Qualitätsmanagerin
Fremdsprachen: Englisch
EDV-Kenntnisse: MS Office
Berechtigungen, Zertifikate: Japanische Sprachkenntnisse von Vorteil, Berufserfahrung 2-5 Jahre

Besondere Leistungen für Mitarbeiter

  • Gesundheitsmaßnahmen
  • ÖPNV-Zuschuss / Tankgutschein
  • vermögenswirksame Leistungen
  • Betriebssport
  • betriebliche Altersvorsorge
  • regelmäßige Weiterbildung
  • Gratisgetränke
  • flexible, familienfreundliche Arbeitszeiten
  • Kita-Zuschuss
Logo: Sysmex-Partec GmbH


Sysmex-Partec GmbH
Arndtstraße 11 a-b
02826 Görlitz


Frau Anne Westermeier
03581 8746 0

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