Regulatory Affairs Specialist

22 May 2026
100%
Permanent position
Berneck

Job summary

Looking for a responsible role in Regulatory Affairs? Join us to manage global market activities and product life cycles!

Tasks

Create and maintain timely regulatory documentation for approvals.
Ensure compliance with EU-MDR and MDSAP regulations across countries.
Collaborate with teams on regulatory strategies and requirements.

Skills

Degree in relevant field with experience in medical device regulations.
Fluent in German and English, both written and spoken.
Strong initiative and ability to work cross-functionally.

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About the job

Are you looking for a responsible position in Regulatory Affairs with an international focus? In this role, you will manage regulatory activities in global markets and accompany products throughout their entire lifecycle. You can expect a varied range of tasks with a high degree of personal responsibility and close collaboration with various departments and a team that wants to achieve something together.

What you can achieve

Creation and maintenance of a lean, gapless, and timely approval documentation
Compliance with regulatory requirements according to MDR and MDSAP as well as other countries
Compilation and processing of approval applications, amendment and renewal applications for various countries, taking into account the applicable regulatory requirements
Processing of regulatory relevant amendment applications
Active participation in the implementation of conformity assessment procedures
Identification and monitoring of country-specific and product-specific regulatory requirements
Communication with authorities and service providers within the scope of approval activities
Integration of new regulatory requirements into existing processes
Support and coordination with various departments in the interpretation and implementation of regulatory requirements
Maintenance and further development of internal and external databases
Creation of global approval strategies for newly developed products
Responsibility for specific product file maintenance according to MDR

What distinguishes you

Completed studies in a relevant field (e.g. medical technology, life sciences, regulatory affairs or comparable) with initial experience in regulatory matters for medical device approvals
Initial experience in the preparation and submission of medical device approval applications in various countries
Knowledge of EU MDR regulations
Very good German and English skills, both written and spoken
Independent, structured and solution-oriented working style
Ability to collaborate across departments
High initiative and decision-making ability

What to expect from us

An open "du" culture and a family-like atmosphere
Comprehensive onboarding as well as an individually designed introduction programme with insights into various departments
Meaningful work that improves the lives of others
At least 5 weeks of holiday plus additional days off
Flexible working hours and the possibility to work partly comfortably from home
Support for professional development through targeted training and further education
Coverage of daily sickness allowance premium
Free parking spaces as well as charging facilities for electric vehicles
Free coffee, tea and fresh fruit as well as 15 minutes paid break

Ready to change the world of eyesight? Then we look forward to receiving your complete application documents. For questions, Fabio is happy to assist you. Direct applications are preferred.