Regulatory Affairs Manager / Regulatory Affairs Specialist / Regulatory Project Manager (Digital Health)

As Regulatory Affairs Manager / Regulatory Affairs Specialist, you will be responsible for managing and implementing compliance and regulatory processes across our digital health business. You’ll work closely with our developers and project managers to translate regulatory requirements into actionable Jira tickets, and ensure these are implemented correctly and documented in line with our quality standards. You’ll also support audits, manage technical documentation, and be a central figure in ensuring we remain compliant with related standards. Interpret and implement regulatory frameworks (e.g., MDR, ISO 13485 for Software-as-a-Medical-Device) within the company. Translate regulatory requirements into technical tickets for developers (e.g., in Jira). Prepare and support internal and external audits and certification processes. Drive improvements in compliance awareness and implementation across the company.