Specialist RA for international registrations (MD and IVD) (all genders)
Dienstgeber: Greiner Bio-One International GmbH
Standort: Kremsmünster, AT, 4550
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, including certificates and submitted documents
- Collaborate and take part in internal and external audits, for example MDSAP Audit program by Notified Bodies
Your profile
- University degree in life science, such as pharmacy or 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 an asset
- Office Package and Outlook
- Ability to work in a team 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. 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.
Vollzeit
Medizintechnik
€ 3.395