Senior Regulatory Affairs Design Quality Engineer

About the role

We are expanding our Regulatory Affairs and Quality Assurance team to support new market introductions, especially in the USA. As a Senior Regulatory Affairs Design Quality Engineer, you will act as the primary liaison with global competent authorities and ensure our medical devices meet all regulatory and quality standards.

Key responsibilities

• Serve as the main contact for interactions with Competent Authorities (FDA, ANSM, TGA, MHRA, Swissmedic) and European Notified Bodies.
• Prepare, argue, and defend technical and regulatory positions for pre‑ and post‑market submissions, audits, and inspections.
• Support engineering teams in design and development to demonstrate compliance with applicable regulations and standards.
• Review and approve quality records, compile technical documentation, and manage 510(k) submissions.
• Own and ensure compliance of QMS processes such as Change Control, Risk Management, and CAPA within the regulatory scope.
• Interpret and apply medical device regulations (EU MDR, FDA QMSR) and drive their implementation across the organization.
• Collaborate cross‑functionally with Engineering, Operations, Marketing, Quality, and Clinical Affairs as a regulatory and quality expert.

Required profile

• Engineer or Master’s degree (or equivalent) with at least 7 years of experience in the medical device industry, preferably orthopedics.
• Strong knowledge of EU MDR, FDA QMSR, and related standards and guidance documents.
• Proven experience interacting directly with Competent Authorities and Notified Bodies.
• Ability to prepare and defend regulatory positions and manage complex submissions.

Required skills

• Regulatory affairs for medical devices
• EU MDR and FDA QMSR compliance
• Technical documentation and 510(k) preparation
• Risk management and CAPA processes
• Change control and quality management systems