Senior Specialist Regulatory Affairs (a)

Bächler Feintech AG seeks a Senior Specialist Regulatory Affairs for its Muntelier/Yverdon-les-Bains sites. The role oversees regulatory strategy, technical documentation, and compliance for medical devices under MDR and FDA regulations.

Elos Medtech, a leading development and manufacturing partner in the medical technology sector, is looking for a Senior Specialist Regulatory Affairs to join its team at the Muntelier and/or Yverdon-les-Bains locations. This position is responsible for driving regulatory strategy, ensuring compliance, and managing technical documentation throughout the product lifecycle for implants, instruments, and components.

Responsibilities

• Oversee the creation and upkeep of technical documentation during all stages of product development.
• Direct regulatory strategy and compliance efforts across the entire product lifecycle.
• Handle CE marking processes under the MDR and manage FDA regulatory submissions.
• Guarantee regulatory compliance and secure product registrations for international markets.
• Lead Post-Market Surveillance (PMS), vigilance reporting, and market monitoring initiatives.
• Serve as the main point of contact for notified bodies, regulatory authorities, and external partners.
• Track changes in regulatory requirements and integrate them into the Quality Management System.
• Collaborate with R&D, Quality Assurance, Clinical Affairs, and other teams to facilitate product development and market access.

Requirements

• A degree in Engineering, Life Sciences, or a related discipline.
• Several years of experience in Regulatory Affairs within the medical device industry.
• In-depth knowledge of European MDR and U.S. FDA regulations, including regulatory submissions and technical documentation.
• A solid understanding of clinical evaluation, biocompatibility, quality management systems, and regulatory compliance processes.
• Fluency in German and English, both written and spoken.

Nice to have

• French language skills.

What the company offers

• An open company culture with 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.

About the company

Bächler Feintech AG operates as a leading development and manufacturing partner for companies in the medical technology sector. The company specializes in the production of implants, instruments, and components for medical technologies. It fosters an open culture with short decision-making processes and an open-door philosophy.

• An open company culture with short decision-making processes and an open-door philosophy.