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Teamleader Regulatory Affairs

Sysmex-Partec GmbH • Görlitz

Bild zur Stelle  Teamleader Regulatory Affairs

Allgemeine Angaben

Arbeitsbereich: Produktion, Bereich Zulassung
Beschäftigungsart: Vollzeit
Tätigkeitsmerkmale:
  • Analysieren
  • Betreuen
  • Kontrollieren
  • Organisieren
  • Personal führen
Arbeitszeit: 40 Std/ Woche
Arbeitsbeginn: per sofort

Stellenbeschreibung

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?

hen we look forward to receiving your application with salary requirements and the earliest possible starting date.

 

Arbeitsort(e):
  • Arndtstraße 11a-b - 02826 Görlitz

Geeignete Berufe / Abschlüsse

  • Produktmanager/Produktmanagerin
Fremdsprachen: Englisch
EDV-Kenntnisse: Office Paket
Berechtigungen, Zertifikate: Grundkenntnisse Japanische Sprachkenntnisse

Besondere Leistungen für Mitarbeiter

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

Firmenangaben:

Sysmex-Partec GmbH
Arndtstraße 11 a-b
02826 Görlitz

www.sysmex-partec.com/

Ansprechpartner:

Herr Alexander Welk
03581 / 87 46 557

Welk.Alexander@sysmex-partec.com

Bitte beziehen Sie sich bei Ihrer Bewerbung auf die Referenznummer jobs-oberlausitz.de/17405.

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