Regulatory Affairs Expert

**General:** * Works independently on tasks and projects within the scope of Product Regulatory Affairs, ensuring compliance with applicable regulations and standards. * Establishes and manages priorities effectively to meet deadlines and align with business and regulatory requirements. * Exercises sound judgment makes informed decisions within their area of responsibility and assumes accountability for outcomes. * Provides technical guidance and support to Junior Regulatory Affairs Experts, fostering their development and ensuring high-quality deliverables. **Your responsibilities:** * Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling * 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. * Ensure compliance with regulatory standards and testing requirements throughout product design and development * Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities * Ensure global regulatory product availability aligned with commercial strategy by managing registrations, renewals, and submissions * Coordinate regulatory product strategies * Drive regulatory assessments for product and process changes, including software updates, patches, cloud‑infrastructure changes * Lead regulatory aspects of product and process changes, including regulatory documentation. **Your profile:** * Master’s degree in Technical, Engineering, or Scientific fields * Minimum of 8-10 years in Regulatory Affairs or Quality Assurance in Medical Devices or Medicinal Products * Knowledge 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 skills * Fluent in English, both written and spoken