Expert Regulatory Affairs (all genders)

Your challenge

• Ensure CE Compliance in the EU for Medical Devices and In Vitro Diagnostics (Creation and update of Technical Dossiers)
• Check and Release of Labelling for Medical Devices and In Vitro Diagnostics
• Perform and Participate in Regulatory Survey Procedures
• Release of Advertisment Material
• Responsible for EUDAMED and SWISSDAMED
• Ensure UK and CH Compliance together with external stakeholders
• Participate in PPWR working group at GBO (RA expert for PPWR)

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 60.977,60 (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.