Senior Regulatory Affairs Design Quality Engineer
To reinforce our Regulatory Affairs and Quality Assurance department, and to continue our business expansion with new market introduction, especially the USA, we are looking to fill the position of Senior Regulatory Affairs Design Quality 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 leveraging your background and demonstrated experience in medical device manufacturing:
* Regulatory Interactions: Primary point of 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 in the context of pre‑ and post‑market submissions (Tech. Doc., 510k, changes notification), audits, inspections, and other queries.
* Design and Development: Support Engineering teams in the design and development of medical devices to demonstrate compliance with regulatory requirements, applicable standards and other relevant regulations. Support risk management activities. Review and approve quality records. Compile and maintain Tech. Doc. and 510(k) as appropriate.
* Compliance: Ensure QMS processes under regulatory team responsibility are applied (Change Control, Risk Management, CAPA, etc.). Act as process owner within scope, guaranteeing compliance, control, and continuous improvement. Ensure obligations regarding importation and distribution of non‑Symbios products are fulfilled.
* Regulatory Intelligence: Interpret and apply medical device regulations, including FDA QMSR and the EU MDR, and play an instrumental and active role in their deployment within the organization.
* Cross‑functional Collaboration: Thrive in cross‑functional environments, inspire open communication with key stakeholders—building trust and fostering strong alignment across Engineering, Operations, Marketing, Quality, and Clinical Affairs. Act as a regulatory/quality expert and ambassador.
Your profile:
* Engineer or Master’s degree (or equivalent) with a minimum of 7 years of significant experience in the medical device industry, preferably in orthopedics.
* Strong knowledge of medical device regulations (specifically EU‑MDR and 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 compiling, submitting, and following up on technical dossiers, including 510(k) submissions.
* Knowledge of risk management per ISO 14971:2019 and associated tools.
* Knowledge of software‑related regulatory requirements is an asset.
* Results‑oriented, with the ability to deliver on time and within defined scope.
* Able to manage multiple projects and priorities in parallel, and to propose pragmatic solutions.
* Analytic, rigorous, autonomous, and collaborative.
* Clear communicator, able to adapt to different audiences while remaining factual and precise.
* Fluent in French and English; German is an asset.
* Preferably located in French‑speaking Switzerland.
Work details:
* Location – 1400 Yverdon‑les‑Bains (VD)
* Workload – 100%
* Employment start – Immediately
* Employment duration – Permanent
* Qualification – Skilled
* Work experience – More than 3 years
* Education – Master’s degree from a university of applied sciences or equivalent
Language skills:
* French – Orally: Very good knowledge, Written: Very good knowledge
* English – Orally: Very good knowledge, Written: Very good knowledge
Contact:
* Email: hr@symbios.ch
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
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