Design Quality Regulatory Affairs Engineer

• 02 octobre 2026
• 100%
• Indefinite duration
• Yverdon-les-Bains

To strengthen our Regulatory Affairs and Quality Assurance department, and to pursue our commercial expansion with the introduction of new markets, notably in the United States, we are looking to fill the position of :

Design Quality Regulatory Affairs Engineer

Reporting to the Regulatory Affairs Manager, you are responsible for the following activities, in accordance with applicable regulatory requirements (EU, US, AU, UK, CH, etc.) and by leveraging your experience and demonstrated track record in medical device manufacturing :

• Regulatory interactions: You are the primary point of contact for interactions with Competent Authorities (ANSM, FDA, TGA, MHRA, Swissmedic, -) and our European Notified Body. You prepare, argue, and defend Symbios' technical and regulatory positions within the framework of pre- and post-market submissions (Technical File, 510k, notification of modifications), audits, inspections and other requests, demonstrating the ability to engage in constructive and efficient exchanges with external regulatory stakeholders while maintaining the necessary sense of urgency.
• Design and development: You support the engineering teams in the design and development of medical devices to demonstrate compliance with regulatory requirements, applicable standards and other relevant regulations. You support risk management activities as needed. Through your engineering and analytical skills, you review and approve quality records to ensure they meet established regulatory and quality requirements. You compile and maintain the Technical File and the 510(k) as needed.
• Compliance: You provide the necessary support to ensure that QMS processes under the responsibility of the regulatory team are applied (Change Control, Risk Management, CAPA, -). You act as process owner within your scope, ensuring their compliance, control and continuous improvement. You are also responsible for ensuring that Symbios' obligations regarding the importation and distribution of non-Symbios products are correctly fulfilled.
• Regulatory monitoring: You interpret and apply medical device regulations, including the FDA QMSR and the European MDR, and play a key and active role in their deployment within the organization.
• Cross-functional collaboration: You thrive in cross-functional environments and have a natural ability to inspire open and targeted communication with key stakeholders - building trust and fostering strong alignment between Engineering, Operations, Marketing, Quality and Clinical Affairs. You act as a regulatory / quality expert and ambassador.

Your profile :

• Engineer / Master (or equivalent) with a minimum of 7 years of significant experience in the medical device industry, preferably in orthopedics.
• Solid knowledge of medical device regulations (notably EU-MDR / FDA QMSR), associated standards and guidance documents.
• Demonstrated experience in direct interactions with Competent Authorities and/or Notified Bodies, including the ability to prepare and defend regulatory positions and respond to technical objections.
• Solid experience in problem solving and manufacturing change control (including RA assessment) in the context of EU and US regulations.
• Experience in the compilation, submission and follow-up of technical files.
• Knowledge of risk management according to ISO 14971:2019 and associated tools.
• Knowledge of regulatory requirements related to software is an asset.
• Results-oriented, with the ability to deliver within defined deadlines and scope.
• Capable of managing multiple projects and priorities in parallel, and proposing pragmatic solutions.
• Analytical, rigorous, autonomous and collaborative.
• Clear communicator, capable of adapting to different audiences while remaining factual and precise.
• Proficiency in French and English; German is an asset.
• Preferably located in French-speaking Switzerland.