Senior Specialist Regulatory Affairs

Das ist der Job

For our site in Muntelier and/or Yverdon-les-Bains, we are looking for a Senior Specialist Regulatory Affairs (a) .

Darum lohnt es sich

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 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 #J-18808-Ljbffr Job Category: QA Job Type: Full Time Job Location: Muntelier / Yverdon-les-Bains Country: Switzerland 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.