ABOUT US
Our employees are our most important asset and the core of our company.
We pride ourselves in offering a dynamic and exciting, but above all supportive and appreciative atmosphere where personal qualities are seen and valued in addition to professional expertise.
We are a growing team of 80+ experts from more than 30 nationalities with offices in Munich, Germany and Krakow, Poland. Together we are inveox!
We pride ourselves in offering a dynamic and exciting, but above all supportive and appreciative atmosphere where personal qualities are seen and valued in addition to professional expertise.
We are a growing team of 80+ experts from more than 30 nationalities with offices in Munich, Germany and Krakow, Poland. Together we are inveox!
YOUR TASKS
You are thrilled to work for a company with high ethical values and would love to have an immense impact on people’s lives by helping release our products?
As our Head of Regulatory Affairs & QM (m/f/d) you’ll lead our Regulatory Affairs & QM team and ensure that our company and our products fulfil the respective national and international regulatory requirements in order to apply successfully for a CE/FDA certification.
As our Head of Regulatory Affairs & QM (m/f/d) you’ll lead our Regulatory Affairs & QM team and ensure that our company and our products fulfil the respective national and international regulatory requirements in order to apply successfully for a CE/FDA certification.
- You are responsible for national and international Medical Device certification application processes and the registration of our products in cooperation with our Product & Technology Teams
- You are responsible for the certification and registration process from approval strategy to documentation, in line with the medical device certification requirements (e.g. ISO, IVDR, MDR, FDA, CFDA) as well as applicable (harmonized) standards
- You plan and carry out clinical trials as part of product release procedures in cooperation with our interdisciplinary project team as well as external partners
- You identify / foresee regulatory requirements and changes (up-to-date regulatory strategy, reaching strategy goals) in order to ensure that our technical product files are up-to-date and comply to the regulatory requirements
- You are responsible for the product-related risk management, from systematically identifying the current state-of-the-art to post-release risk analysis
- You own and oversee our eQMS operations and associated procedures to enable compliance to applicable regulations
- You make sure that our products comply with all applicable global and regional regulatory requirements from labeling over performance to safety elements as well as post market surveillance procedures
- You supervise, guide and lead a growing team of regulatory affairs and quality management specialists to achieve high quality product launches and post market success
