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Regulatory affairs support

Perg
CADS GmbH
€ 40.000 - € 60.000 pro Jahr
Inserat online seit: 18 Februar
Beschreibung

Completed education with a legal, technical, or scientific focus (e.g., Law, Medical Technology, Biomedical Engineering, Computer Science, University of Applied Sciences or University degree).
Basic knowledge or initial experience in Regulatory Affairs for medical devices.
Interest in cybersecurity, artificial intelligence, and their regulatory classification.
Understanding of regulatory frameworks such as MDR, ISO 13485, IEC 62304, IEC 81001-5-1, ISO 14971, and the EU AI Act is an advantage.
Structured, analytical working style with high attention to detail.
Very good German and English skills.
Strong communication skills and enjoyment of interdisciplinary collaboration.
Your Tasks Support development and customer projects in meeting regulatory requirements related to cybersecurity and AI for medical device software.
Contribute to the interpretation and implementation of international regulatory requirements
Support regulatory assessments, documentation, and evidence generation.
Collaborate with project management, software development, quality management, and external partners.
Contribute to building, further developing, and maintaining processes and policies related to cybersecurity and AI regulations.
Support the organizational implementation of new regulatory requirements (e.g., EU AI Act, international regulations).
Help raise organizational awareness of regulatory requirements.
Support internal audits and regulatory-related topics.
The annual salary is 53.802€ gross on a full-time basis according to the IT collective agreement.
Willingness to pay more based upon qualifications and experience.
Instead of corporate policy, you will find collaboration with committed people on an equal footing. Mutual respect and appreciation are very important to us. Our family-like working environment provides the framework for close teamwork and allows sufficient freedom for the individual development of all employees. In the right environment, work is fun—our benefits play a secondary role.
Flexible working hours, home office and workation We always say: What counts is the result and not whether you are present in the office from 8:00 am to 5:00 pm. That is why our team can arrange their time independently and flexibly.
Hardware and equipment It is important to us that our employees have everything they need at their workplace. We are happy to provide our employees with their own notebook, company telephone, etc. if required.
Individual further training opportunities Our employees should always be up to date. That’s why we cover up to 100% of the costs of training and continuing education. Also for books and technical literature.
Company team A fit mind is related to a fit body. That’s why we are happy to pay the participation fee when our team takes part in sports events together.
Sometimes you just need some fun to get back to full power at work. That’s why you can find our team now and then at the football table in our fun corner.
Company events Our employees are often faced with tough challenges, and successes should be celebrated appropriately. That is why we attach great importance to joint employee events.
JobRad Stay fit and eco-friendly with JobRad – whether you’re commuting to work or riding in your free time. Through CADS, you can easily lease the bike of your choice.
Fresh snacks and meals right at the office every day? The “Schrankerl” fridge makes it easy – and we cover 20% of the cost for you!
Diversity of innovation Diverse and forward-looking projects that use innovative technologies to shape medical technology in the long term and make your everyday work exciting.
Free parking in Perg and Ansfelden, and close proximity to the train station.
Group health insurance with premium advantages
About CADS CADS GmbH, based in Perg, in collaboration with the KLS Martin Group, is the world’s leading medical device manufacturer for surgical innovation with its visionary software solutions for professional use.
Digital Health is our Passion. This passion has been the basis of our success for 15 years and makes us a very special employer. We create groundbreaking software solutions that benefit patients and physicians worldwide.
We are constantly working on new developments and industry solutions and see the ideas, skills and potential of our employees as a central component.
You would like to join us on this path and contribute to helping people with your work? Then we would be happy to get to know you and welcome you to our team.

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