Regulatory Affairs Design Quality Engineer / Regulatory Affairs Design Quality Engineeress

Join Our Team at Symbios

Symbios is a leading Swiss medical technology company specializing in custom-made orthopedic implants for hip and knee applications. With 35 years of experience, we have pioneered and continually refined custom implant manufacturing technology, establishing ourselves as the most proficient company in this field globally. Our dedicated workforce of 280 employees across Europe, including over 200 at our Yverdon-les-Bains headquarters, embodies our commitment to excellence.

To reinforce our Regulatory Affairs and Quality Assurance department and support our business expansion, particularly in the USA, we are looking to fill the position of:

Regulatory Affairs Design Quality Engineer

Reporting to the Regulatory Affairs Manager, you will be responsible for a variety of activities in compliance with applicable regulatory requirements (EU, US, AU, UK, CH, etc.), leveraging your background and experience in medical device manufacturing.

Your Responsibilities Include:

• Regulatory Interactions: Serve as the primary contact for interactions with Competent Authorities (ANSM, FDA, TGA, MHRA, Swissmedic, etc.) and our European Notified Body. Prepare, argue, and defend Symbios' technical and regulatory positions during pre- and post-market submissions, audits, inspections, and other inquiries.
• Design and Development: Support Engineering teams in ensuring compliance of medical device designs with regulatory requirements and applicable standards. Review and approve quality records to meet regulatory and quality requirements.
• Compliance: Support the application of QMS processes, acting as the process owner and guaranteeing compliance, control, and continuous improvement.
• Regulatory Intelligence: Interpret and apply medical device regulations (such as FDA QMSR and EU MDR) and facilitate their deployment within the organization.
• Cross-functional Collaboration: Foster effective communication with key stakeholders in Engineering, Operations, Marketing, Quality, and Clinical Affairs, acting as a regulatory and quality expert.

Your Profile:

• Engineer/Master’s degree (or equivalent) with a minimum of 7 years of relevant experience in the Medical Device industry, preferably in orthopedics.
• Strong knowledge of medical device regulations (specifically EU-MDR / FDA QMSR) and associated standards.
• Demonstrated experience in direct interactions with Competent Authorities and/or Notified Bodies.
• Solid problem-solving experience and manufacturing change control expertise within EU and US regulations.
• Experienced in compiling, submitting, and following up on technical dossiers.
• Familiarity with risk management per ISO 14971:2019.
• Knowledge of software-related regulatory requirements is a plus.
• Results-oriented with the capability to deliver on time and within scope.
• Able to manage multiple projects and priorities, proposing pragmatic solutions.
• Analytical, rigorous, autonomous, and collaborative.
• Effective communicator, adaptable to diverse audiences while providing accurate information.
• Fluent in French and English; German is an asset.
• Ideally located in French-speaking Switzerland.

Apply online using the form below. Please note that only applications matching the job profile will be considered.