Regulatory Affairs Specialist
Our client global medical device company is looking for 6 months of support within their Regulatory Affairs team.
Responsibilities
- Creation, review, approval and maintenance of technical files
- Provide regulatory guidance and strategic planning in projects related to compliance EU, US
- Lifecycle management activities
- MDR submission and interactions with a notified body
Requirements
- Strong experience in medical devices with good experience in regulatory affairs
- Very good knowledge of EU, US medical device regulation
- Knowledge in requirements and processes for CE, US submissions
- Experience and knowledge of SaMD regulations will be a plus.
- Fluency in English and French is required; German would be a plus.
Please be aware that only EU citizens and people who have the rights to work in Switzerland are able to apply for this job.
