Job Detail

Hamilton, ein international tätiges Unternehmen, ist einer der Technologieführer in den Bereichen Life Science, Storage, Measurement und Medtec. Hamilton produziert Präzisionsinstrumente für Forschung und Industrie sowie intelligente Beatmungsgeräte. Darüber hinaus ist das Unternehmen in den Wachstumsmärkten Genetik und Robotik stark vertreten. Die Gruppe beschäftigt derzeit weltweit mehr als 2.500 Mitarbeiter, davon mehr als 1.200 in Bonaduz und Domat/Ems im Bündner Rheintal.

Business Unit:

more information

Responsibilities:

• You are reporting directly to the CEO and are responsible for Regulatory Affairs, Quality Management and Vigilance by leading the respective teams (technically and disciplinary)


• You develop the Regulatory Affairs strategy for global registrations including FDA, EU and Asia


• As a member of the management team, and as the responsible person, you guide the transformation related to the MDR (Medical Device Reporting) requirements and set objectives for your department


• You will promote quality awareness within the company and advise your colleagues on quality-related and regulatory requirements


• You and your team work closely with the R&D department and provide early information about the effects of changes in the regulatory and quality requirements


• By monitoring, interpreting and implementing regulatory developments, you will ensure compliance within the company

Qualifications:

• You have a degree in natural sciences or engineering combined with several years (>10 years) of professional experience in Regulatory Affairs and Quality Management in the medical device industry


• Your many years of experience in leadership and personnel management will help you to coach and develop your teams and plan the necessary resources


• Profound knowledge and experiences with regulations: Major QM-Standards: ISO 13485, ISO 9001, 21CFR 820; main regulations: MDD/MDR, IEC60601-1 Serie, IEC62304, IEC14971 and approval procedures: 510(k), Health Canada


• You are familiar with the relevant quality management tools, systems and methods and have a deep understanding of processes and quality


• You have excellent English and German language and communication skills

Are you interested? Then please apply here online by clicking on the "Apply" button. If you have any questions, please do not hesitate to contact:

Applications by post or e-mail can unfortunately not be considered.