Job Title

Regulatory Affairs Senior Expert (m/f/d)Your responsibilities:Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labelingEnsure compliance with regulatory standards and testing requirements throughout product design and developmentCoordinate regulatory approvals and change notifications with Notified Bodies and AuthoritiesEnsure global regulatory product availability aligned with commercial strategy by managing registrations, renewals, and submissionsCoordinate regulatory product strategies Drive regulatory assessments for product and process changes, including software updates, patches, cloud‑infrastructure changesLead regulatory aspects of product and process changes, including regulatory documentation.Your profile:Master’s degree in Technical, Engineering, or Scientific fieldsMinimum of 8-10 years in Regulatory Affairs or Quality Assurance in Medical Devices or Medicinal ProductsKnowledge of development and manufacturing processes Familiarity with quality and risk management standards, including ISO 13485, ISO 14971, IEC 62304 (Software Lifecycle), IEC 82304‑1 (Health Software), and IEC 81001‑5‑1 (Health Software Cybersecurity).Strong knowledge of global medical device regulations, including MDR 2017/745, FDA SaMD Guidance, IMDRF SaMD Principles, NMPA, and requirements for cloud‑based medical software.Experience with cybersecurity, data protection (GDPR), and cloud compliance frameworks relevant to medical devices.Lead regulatory strategy for cloud‑hosted medical software, including data protection, cybersecurity, interoperability, and cross‑border data transfer requirements.Strong communication and interpersonal skillsFluent in English, both written and spoken