Sr RA Design Quality Engineer

Symbios Orthopédie seeks a Senior RA Design Quality Engineer in Yverdon-les-Bains to lead regulatory compliance, manage technical documentation, and support market expansion.

This position sits within the Regulatory Affairs and Quality Assurance team, reporting directly to the Regulatory Affairs Manager. The role is critical for supporting the company’s growth into new territories, particularly the United States, by ensuring all design and quality processes meet strict international standards.

Responsibilities

• Act as the main liaison for European Notified Bodies and Competent Authorities, preparing and defending technical positions during audits and inspections.
• Collaborate with Engineering teams to ensure medical device design and development align with all applicable regulatory requirements.
• Oversee the creation, review, and approval of quality records, including the maintenance of Technical Documentation and the preparation of 510(k) submissions.
• Manage QMS processes such as Change Control, Risk Management, and CAPA, serving as the process owner for compliance and continuous improvement.
• Interpret and implement medical device regulations, including FDA QMSR and EU MDR, driving their adoption across the organization.
• Ensure the company fulfills all legal obligations related to the importation and distribution of products not manufactured by Symbios.

Requirements

• Hold an Engineer or Master’s degree (or equivalent) with at least seven years of experience in the medical device sector.
• Possess deep knowledge of EU-MDR and FDA QMSR regulations, along with associated standards and guidance documents.
• Have a proven track record of direct interaction with Competent Authorities and Notified Bodies.
• Demonstrate strong problem-solving skills and experience with manufacturing change control, including Regulatory Affairs assessments, under EU and US frameworks.
• Be experienced in compiling, submitting, and tracking technical dossiers, specifically 510(k) applications.
• Be fluent in both French and English.

Nice to have

• Prior experience in the orthopedics field.
• Familiarity with risk management principles under ISO 14971:2019 and related tools.
• Understanding of regulatory requirements specific to software.
• Ability to communicate in German.
• Residence in French-speaking Switzerland.

About the company

Symbios Orthopédie fosters a workplace built on cross-functional collaboration, open communication, and mutual trust. The company encourages strong connections between Engineering, Operations, Marketing, Quality, and Clinical Affairs to drive success.

• Emphasis on cross-functional teamwork across all departments.
• Commitment to open and transparent communication.
• Focus on building trust between Engineering, Operations, Marketing, Quality, and Clinical Affairs.