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

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