Regulatory Affairs Engineer (M/F) - Robotics

Role Summary

Reporting to the Customer Quality team of the Robotics activity, you define, manage and secure the regulatory compliance of our robots, AGVs and associated solutions in all target markets (EU, Americas, Asia, etc.), from design to marketing and after-sales monitoring.

Special knowledge

• Project management methodologies
• Compliance and approval of multi-country industrial devices
• Regulatory monitoring and document management
• Negotiation and collaboration with authorities/normative bodies

Quality tools: Audit management, management of regulatory non-compliance, etc.

• Knowledge of the ISO 13485 standard is a plus
• Foreign language: Fluency in English
• Qualities: Team spirit, rigor, integrity, pedagogy

Responsibilities

Your main responsibilities are

• Maintain and improve the inventory of legal obligations in the different countries where our robots are sold
• Structuring the approach in relation to target markets
• Intervene in representation instances (AFNOR type) as compliance representative of the Robotics Division
• Ensure regulatory compliance throughout the development and industrialization cycle and ensure regular updating
• Manage action plans following customer requests for compliance on specific themes (materials, markets, etc.)
• Ensure the representation of Regulatory Affairs during internal, external and customer audits
• Develop synergies with our ESG (Environment, Social and Governance) team on common themes
• Participate in the continuous improvement of the service
• Travel: Punctual

Requirements

• Training: Bac + 5 (Engineer type or equivalent) with a specialization in Quality Management, ideally in regulatory affairs. A different diploma supplemented with significant experience is admitted.
• Experience: Ideally 8 years of experience in a Quality Projects, Compliance and Regulatory Affairs function in an industrial and international environment

Benefits

• Full-time permanent contract, attractive salary and benefits
• Location: Faverges (Haute-Savoie, Auvergne-Rhône-Alpes)

About the Company

Stäubli is a global provider of mechatronic solutions organized around three business areas: Connectors, Robotics and Textile. We are an international group currently present in 29 countries, with agents spread across 50 countries and four continents. Our 6,000 employees share a common commitment to our customers in many industrial sectors in order to offer them comprehensive solutions and long-term support. Founded in 1892 in Horgen near Zurich, the small Stäubli workshop is today an international group based in Pfäffikon, Switzerland, initiator of solutions for all industries and around the world.