Dienstgeber: Greiner Bio-One International GmbH

Standort:
Kremsmünster, AT, 4550

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Reiseausmaß: keine Reisetätigkeiten
Stellentyp: unbefristet
Arbeitsform: hybrid
Your challenge
Planning, coordination and execution of international registrations regarding medical devices and in vitro diagnostics
Planning, coordination and support regarding GMP inspections of international authorities
Overseeing and establishment of international registration strategies
Communication with external stakeholders, authorities and business partners in the course of submissions and answering of deficiency requests
Perform life cycle management and submission of amendments to existing licenses
Oversee MDSAP compliance
Perform legalization of documents according to country requirements
Keep databases up to date (Certificates and submitted documents)
Collaborate and take part in internal and external Audits (e.g MDSAP Audit program by Notified Bodies)
Your profile
University degree in life science (pharmacy, biology)
Profound Regulatory Knowledge in Medtech (Medical Devices and or In Vitro Diagnostics)
English in spoken and written on a business communication level, another language would be definitively an asset
Office Package and Outlook
Ability to work in a team (teamplayer) with high flexibility
Good communication skills
Quick understanding of complex Regulatory Situations
Friendly and professional attitude to represent the company vis a vis outside stakeholders
Ability to work under high pressure and workload peaks
Our offer

We offer you an exciting and independent area of responsibility in a modern and collegial working environment. In addition to numerous attractive social benefits, the gross annual salary for this position is at least EUR 47.532,24 (minimum salary according to the collective agreement for the chemical industry). Depending on your qualifications and professional experience, you may be eligible for a significant overpayment.

If you have any questions or require further information about this job advertisement, please contact Manuela Silbermayr +43 664 8892 0539.

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Wir bieten gleiche Chancen für alle und sehen Vielfalt als unsere Stärke. Daher begrüßen wir Bewerbungen von allen Menschen – unabhängig von Merkmalen wie Geschlecht, Alter, Hintergrund, sozialem Status, sexueller Orientierung, Religion sowie geistigen und körperlichen Fähigkeiten. Es ist unser Ziel, Frauen im Unternehmen zu stärken und den Anteil an weiblichen Führungskräften zu erhöhen. Wir fördern eine inklusive Arbeitsumgebung und ermutigen alle Personen, sich zu bewerben.

Job ID: 4199