Your Responsibilities:

You will be responsible for managing and executing national and international approvals for non-active, sterile single-use medical devices of low and medium risk classifications.

• Preparation and maintenance of the technical documentation for our products

• Automation of technical documentation and digitalization of Regulatory Affairs processes

• Monitoring the global regulatory status of our products and proactively renewing time-limited registrations/approvals, as well as obtaining new approvals in previously untapped markets

• Implementation of new regulatory requirements for our medical devices in collaboration with the Regulatory Affairs & Development management team

• Continuous improvement of our processes, documentation, work instructions, and IT systems

Your Profile:

• Degree in Medical Technology, Engineering, Natural Sciences, or a comparable qualification

• Several years of professional experience in specialized areas such as Clinical Evaluation, Biological Evaluation, Risk Management, Post-Market Surveillance, and Vigilance Activities preferred

• Analytical and structured working style with a strong commitment to quality

• Good command of English, both written and spoken

We Offer:

• Work-life balance: 30 days of vacation and flexible mobile work options

• Challenging and diverse responsibilities

• Attractive compensation (company bike available)

• A collegial atmosphere with flat hierarchies and short decision-making paths

• A respectful and appreciative working environment in the medical technology sector

• Comprehensive onboarding and a wide range of training and professional development opportunities