Head of Regulatory Affairs & QM (m/f)

Our client is a renowned Swiss family-owned company with an international focus. It is committed to improving people's quality of life with high-quality and innovative offerings in specific medical indication areas. On their behalf, we are looking for a leader with several years of experience in Regulatory Affairs within the Medical/Medical Technology environment. Region: Eastern Switzerland / Industry MedTech.

• Healthy Swiss traditional company with global reach
• Highly versatile and strategic role with a lot of personal responsibility and creative freedom
• Attractive employer and manufacturer of an innovative product portfolio

• Professional and personnel management as well as further development of the local Regulatory Affairs team and co-design of the global Regulatory Affairs strategy
• Ensuring regulatory compliance throughout the entire product lifecycle
• Development of regulatory strategies for new products, product changes, and lifecycle management, including technical and regulatory documentation, as well as responsibility for quality management
• Responsibility for international product registrations and market approvals
• Close collaboration with the R&D, Quality Assurance, Operations, Marketing, and Sales departments
• Representing the company in dealings with Notified Bodies, authorities, and international regulatory institutions
• Support of internal and external audits, inspections, and continuous optimization of regulatory processes and systems (ISO 13485)

• Completed studies in Natural Sciences, Medical Technology, Biomedicine, Pharmacy, etc.
• Several years of professional experience in Regulatory Affairs for medical devices
• In-depth knowledge of the EU Medical Device Regulation (MDR 2017/745) is a prerequisite
• Experience in managing complex international approval and registration projects
• Strategic thinking and entrepreneurial action as well as a solution-oriented approach
• Strong communication skills and fluent in German and English

Call us or send us your application documents, stating the reference number JB-202. Roger Stettler looks forward to meeting you personally.