Senior SaMD Quality & Regulatory Lead — Remote

Qbtech; København; Remote; DKK 82,000 - 109,000; Full time

Benefits offered by this job

30 days annual leave

Private health insurance

Pension scheme (ITP1)

Job summary

Qbtech is seeking a Senior Quality & Regulatory Specialist to bridge Product and Software teams with QA/RA. You will support releases, design changes, and risk assessments while ensuring quality and regulatory requirements are integrated throughout the software lifecycle.

You will manage technical documentation, Medical Device Files, regulatory submissions, and market expansion activities, with a focus on eQMS implementation and system validation.

Qualifications

• Several years of experience within Quality & Regulatory in the Medical Device industry, with clear experience in software or SaMD.
• Good knowledge of IEC 62304 and ISO 13485.
• Experience with EU MDR and/or FDA requirements.
• Good understanding of software development and technical documentation.

Responsibilities

• Support Product and Software teams with change management, releases, and risk assessments.
• Ensure Quality and Regulatory requirements are integrated into product development.
• Review and maintain technical documentation and Medical Device Files.
• Contribute to regulatory assessments, submissions, and market expansion activities.
• Implement and further develop Qbtech’s eQMS.
• Support the organisation with risk management, audits, and training.

Skills

Quality & Regulatory

Software lifecycle knowledge

Cross-functional collaboration

Regulatory submissions

Tools

eQMS

Job description

Qbtech is seeking a Senior Quality & Regulatory Specialist to bridge Product and Software teams with QA/RA. You will support releases, design changes, and risk assessments while ensuring quality and regulatory requirements are integrated throughout the software lifecycle.

You will manage technical documentation, Medical Device Files, regulatory submissions, and market expansion activities, with a focus on eQMS implementation and system validation.