Hobson Prior are looking for a Risk Management/Regulatory Specialist (Device role) to join a top pharmaceutical organisation focused on providing better ventilation care to patients living with severe illnesses. This is a permanent role located in Bonaduz.

Job Responsibilities:

• Accountability for the further development and implementation of ISO 14971 in the internal risk management process for medical devices throughout their entire life cycle.
• Ensuring complete risk management documentation.
• Regulatory support for those responsible for the product throughout the entire life cycle of the products and ensuring European conformity.
• Implementation of GAP analyses, preparation of defect reports and training in the corresponding changes.
• Support in the use of innovative ventilation technologies in practice.
• 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.

Key Skills:

• Ability to work in a team.
• Good interpersonal, written and oral communication skills, as well as fluent in German and English.

Requirements:

• Studies in the natural sciences, electrical engineering or medicine or completed vocational training with at least 2 years of practical experience and additional professional training (e.g. master craftsman, technician, specialist diploma).
• Professional experience in risk management / regulatory affairs / quality.
• Knowledge of ISO 14971 and IEC 60601 series.
• Experience in quality management, development, testing and production of medical devices is an advantage.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.