Compliance Officer - AI Medical Software

Our client is an innovative AI-powered medical software company based in Amsterdam, developing advanced technologies that support healthcare professionals, improve patient care and enhance clinical decision-making. As they continue to expand their technology across international healthcare markets, they are seeking an experienced Compliance Officer to take ownership of regulatory compliance, quality management and information security, ensuring their software solutions meet the highest standards of medical device regulation, data protection and cybersecurity.

The role

• Taking ownership of regulatory compliance, quality management and information security activities across the organisation.
• Maintaining and continuously improving the company's Quality Management System (QMS) in accordance with ISO 13485 and applicable medical device regulations.
• Supporting the implementation, maintenance and ongoing certification of an Information Security Management System (ISMS) in accordance with ISO 27001.
• Ensuring compliance with EU MDR (Regulation EU 2017/745) and applicable requirements for Software as a Medical Device (SaMD).
• Overseeing compliance with international data protection and privacy regulations, including GDPR and HIPAA where applicable.
• Developing, reviewing and maintaining compliance policies, standard operating procedures (SOPs), risk assessments and regulatory documentation.
• Coordinating internal and external audits, certification activities and regulatory inspections, including preparation, documentation and follow-up actions.
• Supporting information security risk assessments, cybersecurity controls, data governance and incident management activities.
• Working closely with Software Development, Product Management, Regulatory Affairs and senior management to integrate quality, security and regulatory requirements into product development.
• Supporting software lifecycle management, validation, change control and technical documentation in accordance with applicable medical device software standards.
• Managing non-conformities, Corrective and Preventive Actions (CAPA) and continuous improvement initiatives.
• Monitoring changes to international regulations, standards and industry requirements, assessing their impact on the organisation and implementing necessary improvements.
• Supporting supplier qualification, third-party risk assessments and compliance reviews of external technology and healthcare partners.
• Developing and delivering internal training on quality management, information security, data protection and regulatory compliance.
• Supporting international market expansion by ensuring compliance with relevant healthcare, medical software and information security regulations.

Required experience

• Degree in Biomedical Engineering, Life Sciences, Quality Management, Information Security, Law, Computer Science or a related discipline.
• Professional experience in Compliance, Quality Assurance, Regulatory Affairs, Information Security or Data Protection, ideally within the medical device, digital health or healthcare software industry.
• Strong working knowledge of ISO 27001 and ISO 13485, including implementation, maintenance, auditing and continuous improvement of management systems.
• Good understanding of EU MDR (Regulation EU 2017/745) and its application to medical device software and Software as a Medical Device (SaMD).
• Experience with GDPR and HIPAA, including data protection, privacy requirements and the handling of sensitive healthcare information.
• Experience preparing and maintaining QMS and ISMS documentation, including policies, procedures, risk assessments, audit records and compliance reports.
• Understanding of information security risk management, cybersecurity principles, access controls, incident management and data governance.
• Experience coordinating internal audits, external certification audits and regulatory compliance assessments.
• Familiarity with medical device software standards such as IEC 62304, ISO 14971 and IEC 62366-1 would be advantageous.
• Experience working with AI-driven healthcare technologies, Software as a Medical Device, cloud-based medical platforms or digital health solutions would be highly desirable.
• Knowledge of software validation, technical documentation, change management and regulatory requirements for software development.
• Experience managing CAPA, non-conformities, supplier assessments and compliance improvement initiatives.
• Understanding of international healthcare regulations, particularly requirements relating to the European and US healthcare markets, would be beneficial.
• Relevant certifications in ISO 27001, ISO 13485, information security, privacy or compliance auditing would be advantageous.
• Strong analytical, organisational, documentation and problem-solving skills, with excellent attention to detail.
• Ability to work independently, take ownership of compliance activities and collaborate effectively with technical, clinical and commercial teams.
• Excellent communication and stakeholder management skills, with the ability to translate complex regulatory and technical requirements into practical business processes.
• Fluent English, both written and spoken, with Dutch language skills advantageous.
• Based in Amsterdam or willing to work at the company's Amsterdam-area location.

As a Recruitment Consultant at Aspire Life Sciences, Taylor Lyons specialises in technical and executive hiring across Medical Devices, Neurotechnology, AI, and DeepTech, partnering with innovative organisations across Europe, North America and Asia.