RA/Risk Manager - Global Medical Device company / Switzerland

RA/Risk Manager - Global Medical Device company

The client in Switzerland focuses purely in the Life Science sector where we support the Pharma, Medical Device, Biotech industries and work on QA, Technical and Regulatory positions. With a database that consists of over 2000 Life Science involved talents based in Switzerland and a contact that covers 90% of the job seekers we advertise the clients through all recruitment routes on a daily basis.

Within the range of clients we support big and small players in the industry who are leading organisations that manufacture products for the local and global Life Science markets. A client of theirs, due to their product portfolio growth, have reached out to them for support. In order to strengthen their teams we are looking for a Risk & Regulatory Affairs Manager to join them on a permanent basis.

Tasks:

• Ensuring complete risk management documentation with responsibility of further developing and implementation ISO 14971 in the internal risk management process for medical devices during their entire life cycle
• Carrying out CAPAs, drawing up reports on shortcomings and training on the corresponding changes, with support in the implementation of innovative technologies
• Regulatory support for product managers throughout the entire life cycle, ensuring EU conformity
• Independent representation of the current normative and legal requirements, as well as communication with external testing institutes
• Creation and maintenance of technical documentation, as well as checking the completeness and correctness of project documentation

Requirements:

• Life Science, Electrical Engineering, Medical background or completed training with at least 2 years of practical experience or additional professional training (craftsman, technician, specialist diploma)
• Experience in risk management/Regulatory Affairs or Quality with knowledge in ISO 14971 and IEC 60601
• Quality management, Development, Testing and Production of Medical Devices experience is an advantage
• Ability to work in a team, good interpersonal, fluency in German and English is essential
• Flexible adaptation to changing legal requirements, effective organisation of working time

What is in for you:

• Detailed conversation, introduction and preparation for a successful application with an experienced consultant
• Transparency and support throughout the application process
• Negotiation with clients for better work/contract conditions
• Follow up and update on market relevant opportunities

Experience in within the EU is needed. Please note we can only accept applications from candidates who hold valid European Union passport and are able to work in Europe without visa sponsorship.