Regulatory Affairs Specialist
Posted on Sep 14, 2021 by Helvetica Partners Sarl
We are currently looking on behalf of one of our important clients for a Regulatory Affairs Specialist. The role is a permanent position based in Solothurn Canton.
- Prepare product approval documents for medical devices with authorities worldwide.
- Supervise development projects regarding regulatory affairs.
- Assess amendments.
- Negotiate contracts with customers regarding Regulatory Affairs aspects.
- Correspond & communicate with authorities.
- Assist in customer & authority audits according to ISO 13485 & 21 CFR 820.
- Carry out general QM tasks such as training & the creation of associated documents.
- At least 5 years of professional experience in Regulatory Affairs, including experience with a focus on Medical Devices.
- Any experience in relation to Software & Interactive Medical Products is very advantageous.
- Completed University Degree in Natural Sciences/Engineering or equivalent training.
- Highly motivated, responsible, quality-aware, customer-oriented & communicative.
- Fluent in English (spoken & written), any German language skills are considered a strong plus.
If you wish to apply, please send us your resume in Word format with some references.