Description

Senior Specialist Regulatory Affairs (a)
Elos Medtech is one of the world’s leading development and manufacturing partners for companies in the medical technology sector. With sites in Switzerland, Sweden, Denmark, Germany, China, and the United States, we specialize in the production of implants, instruments, and components for medical technologies.
We are looking for individuals who share our values — passion, trust, and results — so we can grow together and achieve even greater success. If you are ready to give your best and join an environment that values collaboration and commitment, we look forward to receiving your application.
For our site in Muntelier and/or Yverdon-les-Bains, we are looking for a
Senior Specialist Regulatory Affairs (a)
What we are looking for
Lead the creation and maintenance of Technical Documentation throughout the product development lifecycle
Own regulatory strategy and compliance activities across the entire product lifecycle
Manage CE marking activities under MDR and FDA regulatory submissions
Ensure regulatory compliance and product registrations in international markets
Lead Post-Market Surveillance (PMS), vigilance, and market monitoring activities
Act as the primary liaison with notified bodies, regulatory authorities, and external partners
Monitor evolving regulatory requirements and drive their implementation within the Quality Management System
Partner closely with R&D, Quality Assurance, Clinical Affairs, and other stakeholders to support product development and market access
What makes you a great fit
Degree in Engineering, Life Sciences, or a related field, combined with several years of Regulatory Affairs experience in the medical device industry
Strong knowledge of European MDR and U.S. FDA regulations, including regulatory submissions and technical documentation
Solid understanding of clinical evaluation, biocompatibility, quality management systems, and regulatory compliance processes
Fluent in German and English, both written and spoken, French is considered an asset
Willingness to travel within Europe and the US
Structured, proactive, and solution-oriented professional with a high level of ownership and accountability
Excellent communication and stakeholder management skills, with the ability to translate complex regulatory requirements into practical business solutions
Why you’ll love working with us
An open company culture, short decision-making processes, and an open-door philosophy
6 weeks of vacation
Attractive social benefits
Opportunities for individual development
Regular team events
Loyalty bonuses jidbe07276a jit0625a jiy26a