RA Specialist – Berlin
This is the opportunity to join a fast-growing MedTech company within their Regulatory team based in Berlin. You will be part of a young and experienced team working on international regulatory requirements for their high risk medical devices. This is an entry level position seeking a fast learning, ambitious individual with great training opportunities and exposure within the regulatory space.
- preparing and maintaining technical documentation for high risk medical devices.
- communicating with international distributors and completing international registrations of medical devices.
- multi-departmental support specifically with projects in the quality team regarding various quality aspects (CAPA, PMS, change control).
- implementation of MDR requirements.
- BSc or MSc life sciences related discipline or regulatory affairs (advantageous).
- First working experience within the Regulatory or Quality field.
- Thorough knowledge of international approval procedures for the medical device industry.
- Team player with excellent written and verbal communication skills.
- Fluent in German and English.