Specialist RA for international registrations (MD and IVD) (all genders)
Kremsmünster, Upper Austria, Austria · On-site
Mid level
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 authorit…
Skills: International Registrations, Medical Devices, In Vitro Diagnostics, GMP Inspections, Regulatory Strategy
Magaziner:in Für Ersatzteillager mit Einkaufserfahrung (all Genders)
Diepoldsau, St. Gallen, Switzerland · On-site
Mid level
Das machst du bei uns Bearbeitung von Bestellungen auf Basis interner Bedarfsmeldungen Einholen und Vergleichen von Angeboten sowie Prüfen von Preisen und Verfügbarkeiten Preisverhandlungen mit Lieferanten Überwachen von…
Skills: Technical Procurement, Warehouse Management, Inventory Control, SAP, MS Office
Magaziner:in Für Ersatzteillager mit Einkaufserfahrung (all Genders)
Diepoldsau, St. Gallen, Switzerland · On-site
Mid level
Das machst du bei uns Bearbeitung von Bestellungen auf Basis interner Bedarfsmeldungen Einholen und Vergleichen von Angeboten sowie Prüfen von Preisen und Verfügbarkeiten Preisverhandlungen mit Lieferanten Überwachen von…
Skills: Technical Procurement, Inventory Management, Price Negotiation, SAP, MS Office
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Dieses Aufgabenspektrum bieten wir Planung und Abwicklung des Versandprozesses Koordination von Kommissionierung und Verladung Erstellung von Versand- und Begleitdokumenten Abstimmung mit Transportdienstleistern und inte…
Skills: Shipping Logistics, Order Picking Coordination, Shipping Documentation, Transport Provider Coordination, Customer Returns Processing
Specialist RA for international registrations (MD and IVD) (all genders)
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Full-time
bachelor degree
Social Benefits, Modern Working Environment, Collegial Working Environment
Posted 18d ago
~40 hrs/week
Responsibilities
The role involves planning and executing international registrations for medical devices and in vitro diagnostics while managing regulatory strategies. Key duties include coordinating GMP inspections, ensuring MDSAP compliance, and communicating with external stakeholders and authorities.
Requirements
Candidates must hold a university degree in life sciences and possess profound regulatory knowledge in Medtech. Proficiency in English for business communication and the ability to work under high pressure are essential.
Full job description
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.
Related keywords
Medical DevicesIVDRegulatory AffairsGMPMDSAPLife SciencesPharmacyBiologyNotified BodiesInternational RegistrationsComplianceMedtech
Greiner Bio-One specializes in the development, production and distribution of high-quality plastic laboratory products. The company is a technology partner for hospitals, laboratories, universities, research institutes, and the diagnostic, pharmaceutical and biotechnology industries. Greiner Bio-One has specialized in two business division, Preanalytics and BioScience.
The Preanalytics business division, with headquarters in Kremsmünster (Austria), develops and produces innovative collection systems for human and veterinary blood, urine and saliva samples, with the aim of making day-to-day, routine tasks in hospitals, laboratories and doctors’ practices easier and safer. This division also covers customized software solutions (Greiner eHealth Technologies) which ensure greater efficiency and patient safety in the preanalytical process.
Greiner Bio-One’s BioScience division, with headquarters in Frickenhausen (Germany), is one of the leading providers of specialist products for the cultivation and analysis of cell and tissue cultures. Based on decades of experience in the cryopreservation of samples, Greiner Bio-One also offers solutions for automated storage systems in biobanks. In addition, the division also develops and produces microplates for high-throughput screening, which ensure the quickest and most efficient testing of substances and materials in both industry and research.
Greiner Bio-One (then Greiner Labortechnik) was founded in 1963 in Nürtingen (Germany) and started with the manufacture of the first plastic Petri dishes. Today, Greiner Bio-One International GmbH is located in 28 locations in 22 countries. The company employs 2,540 people and is part of Greiner AG, headquartered in Kremsmünster (Austria).
We welcome you to the Greiner Bio-One Americas page, which not only shares global company news but also highlights updates from our subsidiaries in North and South America.
Offices: 4328 Capital Drive, Monroe, North Carolina 28110, US · Bad Haller Straße 32, A-4550, Kremsmünster, AT · Avenida Afonso Pansan, 1967 – Vila Bertini, Americana, São Paulo 13473-620, BR
Greiner Bio-One specializes in the development, production and distribution of high-quality plastic laboratory products. The company is a technology partner for hospitals, laboratories, universities, research institutes, and the diagnostic, pharmaceutical and biotechnology industries. Greiner Bio-One has specialized in two business division, Preanalytics and BioScience.
The Preanalytics business division, with headquarters in Kremsmünster (Austria), develops and produces innovative collection systems for human and veterinary blood, urine and saliva samples, with the aim of making day-to-day, routine tasks in hospitals, laboratories and doctors’ practices easier and safer. This division also covers customized software solutions (Greiner eHealth Technologies) which ensure greater efficiency and patient safety in the preanalytical process.
Greiner Bio-One’s BioScience division, with headquarters in Frickenhausen (Germany), is one of the leading providers of specialist products for the cultivation and analysis of cell and tissue cultures. Based on decades of experience in the cryopreservation of samples, Greiner Bio-One also offers solutions for automated storage systems in biobanks. In addition, the division also develops and produces microplates for high-throughput screening, which ensure the quickest and most efficient testing of substances and materials in both industry and research.
Greiner Bio-One (then Greiner Labortechnik) was founded in 1963 in Nürtingen (Germany) and started with the manufacture of the first plastic Petri dishes. Today, Greiner Bio-One International GmbH is located in 28 locations in 22 countries. The company employs 2,540 people and is part of Greiner AG, headquartered in Kremsmünster (Austria).
We welcome you to the Greiner Bio-One Americas page, which not only shares global company news but also highlights updates from our subsidiaries in North and South America.
Offices: 4328 Capital Drive, Monroe, North Carolina 28110, US · Bad Haller Straße 32, A-4550, Kremsmünster, AT · Avenida Afonso Pansan, 1967 – Vila Bertini, Americana, São Paulo 13473-620, BR