**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 + Robust 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

📌 Regulatory Affairs Expert (Bengaluru)
🏢 Fresenius Medical Care
📍 Bengaluru