Head Regulatory Affairs Medical Technology (m/w)

Top products & intelligent digital solutions.

Are you a person who enjoys seeking solutions to create a good framework for product novelties and approvals? Then there is a leading Swiss medical technology company in the Eastern Switzerland region that definitely wants to get to know you. The globally active manufacturer sells technically high-quality devices and instruments for surgery. The company combines the values of quality, continuity and reliability with dynamism, pioneering spirit and innovation. Region: Eastern Switzerland.

What you can look forward to:

• Exciting, varied activities with freedom for ideas and initiative
• Successful Swiss SME in an international environment and in the innovative healthcare industry
• Attractive and flexible working and employment conditions

Your area of responsibility and tasks:

• Disciplinary and technical leadership as well as support of the RA employees
• Planning, coordination and completion of regulatory activities (MDR 2017/745 and other standards) and international approval procedures for active and non-active medical devices in Switzerland, Europe, USA, CSA and Asia
• Collaboration with the development department
• Creation of technical documentation for medical devices as well as adaptation of existing documentation
• Support of quality management initiatives and usability studies as well as participation in change management
• Technical leadership in interdisciplinary project teams for product approval as a representative of the Regulatory Affairs department
• Maintenance and review of technical product files regarding legal requirements

Your profile:

• Successfully completed higher technical or scientific education at FH or Uni level
• Professional and initial leadership experience in medical technology and in the field of Regulatory Affairs
• Experience in the creation of technical documentation and in the creation of approval documents
• Current knowledge of the normative and regulatory requirements for medical devices
• Very good German and English skills

Contact

Call us or send your application documents stating the reference number JB-211.
Roger Stettler and Anja Weisflog look forward to meeting you personally.

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