About the Role
The role involves leading quality and compliance activities for software-based medical devices, ensuring adherence to international regulatory requirements and information security frameworks throughout product development.
Responsibilities
- Lead quality assurance initiatives for software as a medical device (SaMD) development
- Ensure compliance with medical device regulations including EU MDR and FDA guidelines
- Implement and maintain information security controls aligned with ISO 27001
- Support design control processes in accordance with regulatory standards
- Conduct risk assessments for product development and data handling practices
- Collaborate with engineering teams to integrate compliance into design workflows
- Prepare technical documentation for regulatory submissions
- Manage audits and inspections related to quality and security compliance
- Develop and deliver training on quality and compliance topics
- Monitor evolving regulatory landscapes for impact on product development
- Maintain configuration and document control systems
- Support post-market surveillance and complaint handling processes
- Ensure software lifecycle adherence to IEC 62304 standards
- Facilitate internal quality audits and corrective action planning
- Work closely with clinical and data teams to ensure regulatory alignment
Compensation
Competitive salary and benefits package commensurate with experience
Work Arrangement
Hybrid work model with flexibility for remote and office-based collaboration
Team
Cross-functional team focused on digital health innovation and regulatory excellence
Why This Role Matters
This position plays a critical role in ensuring that innovative digital health solutions meet the highest standards of safety, quality, and regulatory compliance, directly impacting patient trust and market success.
Our Commitment to Innovation
We operate at the intersection of healthcare and technology, advancing software-driven medical solutions that require rigorous compliance and security frameworks to protect users and ensure regulatory approval.
Available for qualified candidates requiring work authorization
