Oertli-Instrumente AG
Berneck
Yesterday
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
