1400 Yverdon-les-Bains, Suisse Posté il y a 2 mois
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: 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 in the context of pre- and post-market submissions (Tech. Doc., 510k, changes notification), audits, inspections, and other queries, demonstrating the ability to engage constructively and effectively with external regulatory stakeholders whilst maintaining the necessary sense of urgency.
Design and Development: You support 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 appropriate. Thanks to your engineering and analytical skills, you review and approve quality records to ensure they meet established regulatory and quality requirements. You compile and maintain Tech. Doc. and 510(k) as appropriate.
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 for those within your scope, guaranteeing 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 appropriately fulfilled.
Regulatory Intelligence: You interpret and apply medical devices regulations, including FDA QMSR and the EU MDR, and play an instrumental 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, purposeful communication with key stakeholders — building trust and fostering strong alignment across Engineering, Operations, Marketing, Quality, and Clinical Affairs. You act as a regulatory / quality expert and ambassador.
Your profile:
Engineer / Master 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.
Experienced in 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.
If you are interested in this challenge, we look forward to receiving your complete application (cover letter, CV, diplomas and work certificates).
