Head of Regulatory Affairs Medical Technology (m/f)

About the job

Top products & intelligent digital solutions.

Are you someone who enjoys finding solutions to create a good framework for product innovations 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 markets 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 work with freedom for ideas and initiative
• Successful Swiss SME in an international environment and in the innovative healthcare sector
• Attractive and flexible working and employment conditions

Your responsibilities and tasks:

• Disciplinary and professional leadership as well as support of 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
• Preparation 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
• Professional leadership in interdisciplinary project teams for product approval as a representative of the Regulatory Affairs department
• Maintenance and review of technical product files for legal requirements

Your profile:

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

Contact

Call us or send your application documents quoting reference number JB-211.
Roger Stettler and Anja Weisflog look forward to meeting you in person.