RegulatoryAffairsExpert

**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. **Regulatory Documentation** * Preparation, maintenance, review, and approval of global regulatory product documentation, including Global Technical Documentation and Registration Files, ensuring strategic alignment and compliance. * Oversee the development, harmonization, and approval of content for Instructions for Use (IFU), Service Manuals (SM), Installation Guides (IGL), and product labeling to meet global regulatory and market requirements. * Serve as a subject matter expert, providing advanced regulatory guidance and interpretation of compliance standards and associated testing strategies. * Advise and collaborate with cross-functional teams on regulatory considerations in design and development projects, influencing product and process decisions. * Manage and approve change notifications submitted to Notified Bodies and Regulatory Authorities, ensuring timely and accurate communication. * Drive and oversee conformity assessments for new medical devices (nMD), medical devices (MD), and other regulated products, ensuring alignment with risk classifications and applicable standards. * Author and validate expert opinions and risk evaluations to support product compliance documentation. * Conduct the preparation of the technical content for Clinical Evaluation Plans and Reports, ensuring robustness and regulatory adequacy. **Product Registration** * Ensure and strategically guide regulatory product availabili