Head Regulatory Affairs Medical Technology (m/f)

Top products & intelligent digital solutions.

Are you a person who likes to seek 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 distributes technically advanced 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 activity with freedom for ideas and personal 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 processes for active and non-active medical devices in Switzerland, Europe, USA, CSA, and Asia
• Cooperation 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 area 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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