Head of Regulatory Affairs (m/f/d), 80-100%

Introduction

For our client, an innovative and successful Swiss company in the medical technology sector, we are seeking an experienced leader as Head of Regulatory Affairs (80-100%). In this key role, you will assume overall responsibility for regulatory matters and ensure that products comply with international requirements throughout their entire lifecycle. You will drive regulatory strategies forward and make a significant contribution to sustainable business success.

Responsibilities

• Professional and personnel management as well as further development of the Regulatory Affairs team
• Responsibility for compliance with international regulatory requirements, especially EU MDR and FDA
• Planning, creation, maintenance and review of technical documentation and approval documents
• Coordination of product approvals, registrations and change procedures in international markets
• Support during audits, inspections, regulatory assessments and CAPA measures
• Close collaboration with Quality Assurance, Development, Production and other internal departments
• Contact person for authorities, notified bodies and external partners
• Monitoring regulatory developments and assessing their impact on products and processes
• Participation in strategic projects to ensure compliance and market access

Profile

• Completed studies in Medical Technology, Biomedical Engineering, Life Sciences or a comparable field
• Several years of professional experience in Regulatory Affairs in the medical technology environment
• Leadership experience and enthusiasm for developing employees
• Sound knowledge of the EU MDR and ideally other international regulations (e.g. FDA)
• Experience with technical documentation and approval procedures
• Analytical, structured and solution-oriented working style
• Strong communication and organisational skills
• Very good German and English skills, both spoken and written

Benefits

• Responsible leadership position with great scope for design
• Exciting and varied field of activity in a future-oriented industry
• International environment with innovative products and technologies
• Short decision-making paths and the opportunity to contribute your own ideas
• Attractive employment conditions with a 4.5-day week and 5 weeks of holiday
• Motivated team as well as an open and appreciative corporate culture

• Long-term perspective in a successful Swiss company

Contact Information

If you have any further questions about this job offer (Reference: JN -102026-1182103), please contact Andrina Stäubli at +41 58 233 20 21.

About Us

Adecco is the market leader for personnel solutions in Switzerland and worldwide. Every day, our teams at around 50 locations across Switzerland ensure the best match between candidates and clients in various professional fields and industries.

Adecco Switzerland is a company of the Adecco Group, the world’s leading talent advisory and solutions company. We believe in preparing everyone for the future and employ over 3.5 million people daily. We recruit, develop and train talents in 60 countries and enable organisations to help shape the future of work.