Expert Regulatory Information Management
vor 23 Stunden
**Your Tasks**: - Definition, maintenance and further development of processes to ensure regulatory compliant approval of FME medical devices worldwide - Creation and provision of regulatory documents for the global registration of FME medical devices - Consulting and supporting all involved parties in the global registration of FME medical devices to ensure timely access to all relevant markets - Planning, documenting, monitoring, reporting and tracking of projects in the RIM (regulatory information management) area - Provision of information on regulatory status (registrations) for all FME medical devices - Implementation and maintenance of a regulatory information management system (RIMS) including a process to steer and control registration activities world-wide (e.g., workflow-based) in accordance with pre-agreed roadmaps - Support Verticals (business units) by creating and provisioning central documents needed for registrations including notarization, apostillation or embassy certifications **Your Profile**: - Master in engineering or natural science - Professional experience (> 5 yrs) in internationally acting companies; thereof min. 3 yrs. in the medical device industry in the area of regulatory affairs or quality management - Excellent stakeholder management and communication skills, supporting transparent dialogue without avoiding conflicts - Willingness to continuously learn and adapt to changing environments - Strong expertise in RA and global regulatory requirements - Comprehensive experience and proven track record in handling new developments, product registrations and maintenance of products - Strong project management skills, highly structured and systematic working style - Excellent knowledge of FME business and products - ability to interact with all management levels to influence positive change - Fluent in business English - Additional language skills are a plus, e.g. German - Willingness to travel in the scope of meetings, workshops, conferences, etc.
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Experte Central Management Regulatory Services
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EU Regulatory Lead
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Non-financial Risk Management
Vor 3 Tagen
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Frankfurt am Main, Deutschland Deutsche Bank Vollzeit**Über diese Position**: Das Central Management Regulatory Service steuert und verantwortet zentral alle regulatorischen den Corporate Bank Deutschland Vertrieb betreffenden Themen mit einem Schwerpunkt auf Know Your Client - KYC und greift damit auf ein Portfolio von 950k Kunden zu. Dies beinhaltet u.a. die Pflege und Kontrolle der Kundendaten und...
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Regulatory Management Oversight Associate
Vor 3 Tagen
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Manager, Regulatory Affairs
vor 1 Woche
Frankfurt am Main, Deutschland Alimentiv VollzeitManager, Regulatory Affairs (Europe)Management of Regulatory Affairs personnel through line management and project delivery oversight. Responsible for developing study regulatory strategies and leading department initiatives. The role involves collaboration with other departments to support the successful approval of clinical trials. May have...
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Senior Regulatory Adherence and Policy Management
vor 22 Stunden
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Senior Regulatory Management Advisor-regulatory
vor 22 Stunden
Frankfurt am Main, Deutschland Deutsche Bank Vollzeit**Über den Bereich** Regulatory Affairs verantwortet die Interaktion zwischen Deutscher Bank und ihren wichtigsten Aufsichtsbehörden weltweit. Regulatory Management Germany (RMG GY) hierbei insbesondere die Europäische Zentralbank (EZB), BaFin und Bundesbank als Heimataufsichtsbehörden sowie den Single Resolution Board (SRB) und die BaFin als...
