Regulatory Affairs/ Quality Assurance Coordinator - Switzerland

Regulatory Affairs / Quality Assurance Coordinator - Ventilation related Medical device products - Switzerland - English essential

Are you looking for a step into the Medical devices industry but are short on industry experience ?

Have you completed training/study/internship in Quality, Regulatory Affairs, post market surveillance, or clinical that would you prepare you for a career in post market surveillance and vigilance reporting ?

Our client is a Swiss based medical devices manufacturer with 2 sites in Switzerland and with it's parent company a global leader in respiratory/ventilatory products. A maternity leave (12 month) position has just opened up for a Vigilance specialist to take on routine but essential tasks within their RAQA department.

Daily responsibilities to include
- Distribution of Field Safety Notice to all affected distributors.
- Collection of response forms from distributors and sending reminders to distributors as required by the FSCA (field safety corrective actions).
- Report on weekly basis the progress on the effectiveness of the distributors responses forms received
- Monitor and follow up on customer requests and direct them to the right person to prepare the technical answer
- Provide support filling in reports to Competent Authorities on FSCAs and incidents reporting.
- Coordinate the closure of NCs and CAPas

Requirements:
- Very good knowledge with MS Office
- Detailed oriented person
- Good level of English - verbal and written.
- Good communication skills

This will be a quick turnaround position as the incumbent is in the process of leaving. Interviews will be arranged at short notice.

While a technical background and immediate experience working in the Medical Devices sector is preferred, the Quality and Regulatory driven processes can be taught - we will consider graduates with internships or some relevant industry experience, also professionals with a more Administrative background but strong attention to detail.

For more information on this vacancy, or any other QA opportunities within the Swiss Medical Devices sector, please contact the Senior Consultant Andrew Boroky on 0041 43 50 80 816, or email him at quality@nonstop-devices.com together with scanned certifications of training and Arbeits Zeugnisse.

For industry news and new opportunities in QA within the Medical Devices and Diagnostics sectors, please join my Linked group at ch.linkedin.com/in/qaswitzerland/en

KEY WORDS: Vigilance, adverse event, incident, post market surveillance, Complaints, Switzerland, Quality Assurance, Compliance, CAPA, Medical Devices, German, English, 21 CFR 820, MDR, MDD, ISO 13485 / IEC 60601, product recalls, FSCA, audit, regulatory, health authorities, distributor, notified body, Medical Device jobs, Nonstop recruitment, Manufacturing, Engineering

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.