Regulatory Affairs ExpertFresenius Medical Carefull-timeRequired skillsbusiness objectiveschange managementcompliancecross-functionalAbout the role Fresenius Medical Care Website: freseniusmedicalcare.com Job details: 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 DocumentationPreparation, 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 RegistrationEnsure and strategically guide regulatory product availability in global markets in support of the company’s business objectives and commercial strategy.Maintain oversight of global regulatory requirements and activities, providing expert coordination and direction to regional teams and stakeholders.Define, align, and communicate regulatory strategies and roadmaps in partnership with cross-functional and regional partners.Oversee the execution and maintenance of product registrations, renewals, and submissions worldwide, resolving complex regulatory challenges proactively.Direct the compilation of standardized global registration files (e.g., STED) and lead their adaptation for local submissions.Approve Free Sale Certificates and declarations for regulatory submissions, ensuring accuracy and compliance.Lead the registration of medical devices (including trading goods and kits), production sites, and new production lines, ensuring adherence to applicable laws and guidelines.Provide senior-level support and strategic input for pharmaceutical registrations where medical devices are classified as medicinal products.Represent Regulatory Affairs in tenders, delivering regulatory documentation and strategic input as needed.Change ManagementChair or lead participation in design change councils, providing authoritative regulatory direction on change control processes.Evaluate, approve, and guide the implementation of complex product and process changes from a global regulatory perspective.Lead global communication and alignment of regulatory changes across regions and stakeholders, ensuring consistency and compliance.Oversee and validate local assessments of regulatory impacts and drive resolution of feedback and challenges.Monitor and report on the implementation of changes, maintaining high-level oversight of status, risks, and mitigation plans.Act as regulatory project leader for significant change initiatives, ensuring timely delivery and compliance.Support, Creation, and ReviewLead the drafting, review, and approval of Declarations of Conformity and related compliance documentation.Oversee the creation, maintenance, and governance of Product Center Information and other regulatory data repositories.Provide senior-level review and decision-making on Additional Information (AI), Supplementary Requests (SR), and other regulatory inquiries.Guide and approve product-related technical documentation, marketing materials, and other customer-facing content from a regulatory standpoint.Maintain, review, and enhance the global list of applicable standards, ensuring currency and alignment with evolving regulatory landscapes Click on Apply to know more. This page is fully interactive when JavaScript is enabled. Please enable JavaScript to apply or browse related roles.