Regulatory Affairs Design Quality Engineer

Regulatory Affairs Design Quality Engineer

05 Mai 2025

To strengthen our Regulatory Affairs and Quality Assurance department, we are currently looking for a :

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:

1. Quality processes: You provide support to ensure processes under the responsibility of the regulatory team are applied. You act as a "process owner" for those you oversee, guaranteeing their compliance, control, and continuous improvement. You manage the Change Control process, including RA assessments for reportability to regulatory bodies (e.g., Notified Body, FDA, TGA) and NB notifications/submissions. You also ensure Symbios' responsibilities regarding the importation and distribution of non-Symbios products are properly managed.
2. Design and Development: You support Engineering teams in designing and developing medical devices to ensure regulatory compliance, standards application, and regulatory requests. You assist with risk management activities and review/approve quality records to meet regulatory and quality standards.
3. Technical dossiers: You prepare and maintain product technical dossiers, including all regulatory records.
4. Analysis and deployment of regulatory requirements: You interpret and apply regulations such as MDR and 21 CFR, actively contributing to their deployment within the organization.
5. Cross-functional collaboration: You work closely with Engineering, Operations, Marketing, Quality, and Clinical Affairs teams.
6. Audits and inspections: You participate in internal and external audits.
7. Training and Communication: You serve as a regulatory and quality expert, promoting continuous improvement of QMS processes.

Your profile:

1. Engineer or Master’s degree (or equivalent) with at least 3 years of significant experience in the Medical Device industry, preferably in orthopedics.
2. Strong knowledge and experience in manufacturing change control (including RA assessments) for medical devices within EU and US regulations.
3. Familiar with medical device regulations (e.g., EU-MDR, 21 CFR), standards (ISO 13485:2016), and guidance.
4. Knowledge of risk management per ISO 14971:2019 and related tools.
5. Experience in submitting and managing technical dossiers, including 510(k).
6. Understanding of quality management principles and problem-solving tools (e.g., 6M, 5 Why).
7. Knowledge of software-related regulatory requirements is an asset.
8. Objective-driven, focused on delivering on time and within scope.
9. Capable of managing multiple projects and priorities simultaneously and proposing pragmatic solutions.
10. Analytical, rigorous, autonomous, collaborative, and a team player.
11. Effective communicator tailored to different audiences, clear and precise.
12. Fluent in French and English; German is an asset.
13. Preferably based in French-speaking Switzerland.