Regulatory Affairs Design Quality Engineer (Medical Devices)

About the role

Symbios is expanding its business into new markets, especially the USA, and wants to strengthen its Regulatory Affairs and Quality Assurance department. It is looking for a Regulatory Affairs Design Quality Engineer (100%) based in Yverdon-les-Bains, reporting to the Regulatory Affairs Manager. The role covers regulatory interactions, design and development support, compliance and regulatory intelligence, and requires a background in medical device manufacturing.

Key responsibilities

• Act as the main contact for interactions with competent authorities (ANSM, FDA, TGA, MHRA, Swissmedic, etc.) and the European Notified Body, preparing and defending technical and regulatory positions for pre- and post-market submissions, audits and inspections.
• Support engineering teams in designing medical devices so they comply with regulations and standards, and support risk management activities.
• Review and approve quality records, and compile and maintain Technical Documentation and 510(k) files.
• Ensure QMS processes such as Change Control, Risk Management and CAPA are applied correctly, and act as process owner for them within your scope.
• Ensure Symbios' obligations regarding the import and distribution of non-Symbios products are met.
• Interpret and deploy medical device regulations, including FDA QMSR and the EU MDR, within the organization.
• Collaborate across Engineering, Operations, Marketing, Quality and Clinical Affairs as a regulatory and quality expert and ambassador.

Required profile

• Engineer or master's degree (or equivalent) with at least 7 years of significant experience in the medical device industry, preferably orthopedics.
• Demonstrated experience interacting directly with competent authorities and/or notified bodies, including preparing and defending regulatory positions.
• Experience in problem solving and manufacturing change control (including RA assessment) under EU and US regulations.
• Experience compiling, submitting and following up on technical dossiers.
• Fluent in French and English; German is an asset. Preferably located in French-speaking Switzerland.

Required skills

• Strong knowledge of EU-MDR and FDA QMSR regulations, associated standards and guidance documents.
• Risk management according to ISO 14971:2019.
• Software-related regulatory requirements are an asset.