2 meilleures offres (regulatory affairs specialist, vaud) (à pourvoir)

Senior Specialist Regulatory Affairs
Elos Medtech —Yverdon-les-Bains, VD
- 100%
- Gestion du personnel
- Anglais
- Compétences en communication
Senior Medical Scientist - Systemic Pain
Haleon —Nyon, VD
- 100%
- Technologies de l'information
- Compétences en communication

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Senior Specialist Regulatory Affairs

Elos Medtech -
Yverdon-les-Bains, VD

Soumettre votre candidature

Détails de l'emploi

100% | Temps de travail : 90-100%

Qualifications

Français
Gestion du personnel
Anglais
Compétences en communication
Allemand

Description complète du poste

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.

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
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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regulatory affairs specialist emplois - vaud

Senior Specialist Regulatory Affairs

Senior Medical Scientist - Systemic Pain

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