Head of Regulatory Affairs & QM (m/f)

Our client is a renowned Swiss family business with an international orientation. In certain medical indication areas, it is committed to improving people's quality of life with high-quality and innovative offerings. On its behalf, we are looking for a leadership personality with several years of experience in the field of Regulatory Affairs in the medical/medical technology environment. Region: Eastern Switzerland / Industry MedTech.

What you can look forward to:

• Healthy Swiss traditional company with global reach
• Highly versatile and strategic activity with a lot of personal responsibility and scope for design
• Attractive employer and manufacturer of an innovative product portfolio

Your area of responsibility and tasks:

• Functional and personnel leadership as well as further development of the local Regulatory Affairs team and co-shaping 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 cooperation with the departments R&D, quality assurance, operations, marketing and sales
• Representation of the company towards Notified Bodies, authorities and international regulatory institutions
• Support of internal and external audits, inspections as well as continuous optimization of regulatory processes and systems (ISO 13485)

Your profile:

• Completed studies in natural sciences, medical technology, biomedicine, pharmacy etc.
• Several years of professional experience in the field of Regulatory Affairs for medical devices
• Sound knowledge of the EU Medical Device Regulation (MDR 2017/745) is a prerequisite
• Experience in leading complex international approval and registration projects
• Strategic thinking ability and entrepreneurial action as well as solution-oriented way of working
• Strong communication skills and proficient in negotiation in German and English

Contact

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

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