Our Client Global Medical device company is looking for a Regulatory Affairs Specialist for their Swiss office.
The Regulatory Affairs Specialist will join the Regulatory team and will help with upcoming Global MDR submission and inspection.
Responsibilities:
- Creation, review and approval of technical files, Canadian registrations and US 510(k) submissions.
- Ensuring timely maintenance activities for EU, US & CA including ECOs, STEDs, GSPRCs
- Provide regulatory guidance and strategic planning in projects related to compliance EU, US & CA
Requirements:
- Strong experience from Medical devices in the field of Regulatory Affairs
- Very good knowledge of EU, US, and CA medical device regulation
- Knowledge of medical device quality management systems 21 CFR Part 820 and ISO 13485
- Project management skills
- Fluency in English, German is a plus
Only EU citizens and people who have working rights in Switzerland are preferred.
If you are interested, please apply or contact me directly on