Senior Regulatory Design Quality Engineer (Medical Devices)

Symbios; United States; À distance; USD 120 000 - 150 000; Plein temps

Résumé du poste

Symbios is seeking a Regulatory Affairs Design Quality Engineer to reinforce its regulatory and quality assurance team in the USA. The role focuses on handling regulatory interactions, design support, and ensuring compliance with EU and US requirements, including MDR and QMSR.

Ideal candidates have 7+ years in medical devices, experience with authorities and Notified Bodies, and strong risk management knowledge. Fluency in English and French is preferred, with Swiss-French ties noted.

Qualifications

• 7+ years in the medical device industry.
• Strong knowledge of EU MDR and FDA QMSR.
• Direct interactions with Authorities/Notified Bodies.
• Experience in EU/US regulatory change control (RA Assessment).
• Experience compiling and submitting technical dossiers.

Responsabilités

• Regulatory Interactions: primary contact with authorities and Notified Bodies.
• Design and Development: support device design to meet regulatory requirements; review quality records.
• Compliance: support for QMS processes; ensure regulatory obligations are fulfilled.
• Regulatory Intelligence: interpret medical device regs (EU, US) and apply uptake.
• Cross-functional collaboration: align with Engineering, Operations, Marketing, Quality, Clinical Affairs.

Connaissances

Regulatory affairs

Quality systems

Medical devices

ISO 14971

EU MDR

FDA QMSR

Competent Authorities

Notified Bodies

Regulatory submissions

Cross-functional collaboration

Formation

Master's degree in engineering

Description du poste

Symbios is seeking a Regulatory Affairs Design Quality Engineer to reinforce its regulatory and quality assurance team in the USA. The role focuses on handling regulatory interactions, design support, and ensuring compliance with EU and US requirements, including MDR and QMSR.

Ideal candidates have 7+ years in medical devices, experience with authorities and Notified Bodies, and strong risk management knowledge. Fluency in English and French is preferred, with Swiss-French ties noted.