Sen Manager QARA, EMEA - MedTech-Cosmetics-Nutritionals

Quality Management and Regulatory Affairs Manager - Swiss MedTech - Key role and management team representative - German/English essential

Today I am working with a Swiss medical technology company headquartered in German speaking Switzerland - development, manufacture, and sale of non-invasive patient monitoring solutions. They are a small to medium size company growing organically and excitingly also through acquisition, and now with a need for a QM / RA Manager to be based at the newly acquired site and holding overall responsibility for Quality management and Regulatory Affairs. This means:
- Responsibility for maintaining, updating and improving the Quality management system and ensuring compliance to EN ISO 13485, & MDR
- Responsibility for approval of products
- Implementation of internal and external audits, and communication with relevant authorities

What they need in terms of education and experience?
A Life Sciences degree/Diploma in the Life Sciences or Engineering, with a good technical understanding, and ideally industry experience in Quality and Regulatory Affairs within the Medical Devices sector. Product experience not essential, however given the electromechanical nature of the products, experience with software-operated devices is advantageous, as is ISO 60601 and with ISO 62304 a plus. Some CE marking experience and in the preparation and submission of dossiers is important.
Very good English and German language skills are crucial, with proven ability in communicating and convincing multiple audiences of Quality compliance and essential tasks.

Exciting times as the company builds on current successes in their market. If this sounds like it is you, then please apply today to 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: QMS, Quality Management System, Germany, Switzerland, Quality Assurance, Risk Management, Compliance, CAPA, Medical Devices, electrical, mechanical, software, French, German, ISO 13485, ISO 60601, ISO 62304, MDR, Regulatory Affairs, Registration, Competent Authority, 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.