Ihre Herausforderung

• 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)

Ihr Profil

• 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

Unser Angebot

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.

If you are passionate about promoting innovative medical devices and possess the skills and experience outlined above, we encourage you to apply for this exciting opportunity to join our dynamic team at GBO. Please submit your resume and cover letter detailing your relevant experience and qualifications. We look forward to hearing from you!