Regulatory Affairs Design Quality Engineer

Responsibilities :

Reporting to the Regulatory Affairs Manager, you are responsible for the following activities, in accordance with the applicable regulatory requirements and leveraging your background and demonstrated experience in medical devices manufacturing:

• Quality processes: You provide the necessary support to ensure processes under the responsibility of the regulatory team are applied, and you act as a "process owner" for those for which you are responsible, to guarantee their compliance, as well as their control and continuous improvement. In particular, you are in charge of the Change Control process, for which you also carry out the associated RA assessment to determine the reportability to the regulatory bodies (e.g. Notified Body, FDA, TGA, …) and manage NB notifications/submissions as appropriate. You are also responsible for ensuring that Symbios’ responsibilities regarding the importation and distribution of non-Symbios products are appropriately applied.
• Design and Development: You support the Engineering teams in the design and development of medical devices to demonstrate their compliance with regulatory requirements, the application of standards or for any request related to applicable regulations. You support risk management activities as appropriate. You use your engineering and analytical skills by reviewing and approving quality records related to medical devices to ensure they meet established regulatory and quality requirements.
• Technical dossiers: You draw up and maintain product technical dossiers, including records specific to regulatory aspects.
• Analysis and deployment of regulatory requirements: You can interpret and apply medical devices regulations, such as the MDR and 21 CFR, and you play an active role in their deployment.
• Cross-functional collaboration: You work closely with the Engineering, Operations, Marketing, Quality and Clinical Affairs teams.
• Audits and inspections: You take part in internal and external audits.
• Training and Communication: You act as a regulatory / quality expert and ambassador to ensure the application and continuous improvement of QMS processes.

Your profile:

• Engineer / Master degree (or equivalent) with minimum 3 successful years of significative experience in the Medical Device industry, preferably in orthopedy.
• Solid knowledge of and demonstrated experience in manufacturing change control (including RA Assessment) applied to medical devices, specifically in the frame of EU and US Regulations.
• Familiar with medical device regulations (e.g. EU-MDR, 21 CFR), including standards (such as ISO 13485:2016) and associated guidance.
• Knowledge of risk management according to ISO 14971:2019 and associated tools.
• Knowledge and experience of submitting and following up technical dossiers, including 510(k).
• Familiar with quality management principles, including problem solving tools (e.g. 6M, 5 Why).
• Knowledge of software-related regulatory requirements is an asset.
• Objective-driven (focus to deliver on time and within the defined scope).
• Ability to manage multiple projects and priorities in parallel, and to propose pragmatic solutions.
• Analytic, rigorous, autonomous, collaborative and team player.
• Know how to adapt your communication to different target audiences by being factual, precise and easy to understand.
• Fluent in French and English; German an asset.
• Preferably located in French-speaking Switzerland.