Director Regulatory Information Management

vor 2 Wochen


Frankfurt Am Main, Deutschland Fresenius Medical Care Vollzeit

**In your role as** Director Regulatory Information Management (M/F/d) you will be responsible for provision of information on regulatory status (registrations) for all Care Enablement products including regulatory KPIs.

**Your assignments**
- Implementation and maintenance of a registration 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
- Owner of FMEs worldwide registration process for medical devices
- Regulatory strategy, portfolio and resource management:

- Definition and alignment of regulatory strategies for all Care Enablement (FME’s medtech company including production) products and systems
- Provision of regulatory input to portfolio management process and coordination of needed actions
- Inform country RA organizations concerning roadmaps of business units (In-Center, Home and Critical Care) and prioritization support as well as active resource management support
- Provision of digital overview on running regulatory projects including status
- Support business units by creating and provisioning central documents needed for registrations including notarization, apostillation, or embassy certifications

**Your profile**
- Successfully completed Master studies in engineering or natural science, similar field of specialization
- Additional qualification such as RA manager training courses
- Strong expertise in RA and global regulatory requirements. Several years of comprehensive leadership experience with familiarity of leading diverse teams in global (matrix) environments; thereof minimum 5 years in RA or Quality Management
- 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
- Experience with introduction, maintenance, and usage of RIMS software, e.g., IQVIA rim smart, Veeva Vault RIM, Rimsys, etc.
- Willingness to continuously learn and adapt to changing environments
- Fluent in business English, German language is an advantage, further languages are a plus, e.g., Spanish



  • Frankfurt, Deutschland Real Staffing Vollzeit

    Ein spannendes Unternehmen aus Hessen sucht zum nächstmöglichen Eintrittstermin einen Director (m/w/d) Regulatory Affairs & Quality Management in unbefristeter Festanstellung. Ihr Aufgabengebiet:Entwicklung und Leitung wettbewerbsfähiger und innovativer Regulierungsstrategien und Sicherstellung der Einhaltung der Vorschriften während des gesamten...

  • Cib Operations

    Vor 7 Tagen


    Frankfurt am Main, Deutschland JPMorgan Chase & Co Vollzeit

    **JOB DESCRIPTION** The COO Office supports the JPMSE Head of OOT (Head of Operations, Outsourcing & Technology) across the full functional remit (Operations, Regulatory Reporting, Outsourcing, Technology, Resiliency and Data Governance) with matters relating to Boards governance, regulatory reporting, Audit and Regulatory engagement quality assurance. We...


  • Frankfurt am Main, Deutschland MFS Investment Management Vollzeit

    At MFS, you will find a culture that supports you in doing what you do best. Our employees work together to reach better outcomes, favoring the strongest idea over the strongest individual. We put people first and demonstrate care and compassion for our community and each other. Because what we do matters - to us as valued professionals and to the millions...


  • Frankfurt Am Main, Deutschland Fresenius Medical Care Vollzeit

    Establish, implement and lead regulatory and quality strategies to actively support Fresenius Medical Care's Business in adequate time and way. Ensure product safety, quality and regulatory compliance in accordance with applicable laws and standards in all countries in scope of the hub. **Your assignments**: - Establish QR structures, national teams to...

  • Regulatory Officer

    Vor 7 Tagen


    Frankfurt Am Main, Deutschland Viatris Vollzeit

    Mylan Germany GmbH At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...

  • Managing Director

    Vor 4 Tagen


    Frankfurt am Main, Deutschland MFS Investment Management Vollzeit

    At MFS, you will find a culture that supports you in doing what you do best. The Managing Director will use their discretion and judgment, this position works with the Senior Managing Director - EMEA , in developing, implementing, communicating and monitoring sales strategy for Germany. The Managing Director will also work closely with the rest of the sales...


  • Frankfurt am Main, Deutschland ProClinical Vollzeit

    **Salary**: Highly Competitive Job type: PermanentDiscipline: Data Management**Location**: Germany- Frankfurt, Germany - Posting date: 27 Feb 2024 Reference: 59161 Proclinical are partnering with a pharmaceutical organisation who are recruiting for an individual to join their team. This role is on a permanent basis with the ability to work remotely from...


  • Frankfurt (Oder), Brandenburg, Deutschland Selby Jennings Vollzeit

    Job Summary:Our client, a leading international banking group committed to providing innovative financial solutions based in Frankfurt, is seeking a highly skilled and motivated Outsourcing Director/VP to join their team. As the Outsourcing Director/VP, you will play a pivotal role in overseeing and managing outsourcing activities within the organization....


  • Frankfurt am Main, Deutschland JPMorgan Chase & Co Vollzeit

    **JOB DESCRIPTION** As a Finance and Business Management Regulatory Reporting Associate in the financial reporting team you will be actively involved in the monthly, quarterly and annual financial regulatory submissions, as well as addressing Regulatory queries. You will support ad-hoc Regulatory requests that should be handled with very tight timelines in...


  • Neuhaus am Rennweg, Deutschland Röchling Group Vollzeit

    Back **Assistenz Global Director Quality & Regulatory Affairs (m/w/d)**: **Eine Stelle in** - Vollzeit**Berufslevel** - Berufserfahrene**Einstiegszeitpunkt** - ab sofort**Bereich** - Medical**Standort** - Neuhaus am Rennweg- Online bewerbenPDF DownloadWir suchen für unseren Standort in Neuhaus am Rennweg zum nächstmöglichen Zeitpunkt eine **Assistenz...


  • Neuhaus am Rennweg, Deutschland Röchling Group Vollzeit

    Back **Assistenz Global Director Quality & Regulatory Affairs (m/w/d)**: **Eine Stelle in** - Vollzeit**Berufslevel** - Berufserfahrene**Einstiegszeitpunkt** - ab sofort**Bereich** - Medical**Standort** - Neuhaus am Rennweg- Online bewerbenPDF DownloadWir suchen für unseren Standort in Neuhaus am Rennweg zum nächstmöglichen Zeitpunkt eine **Assistenz...


  • Frankfurt am Main, Hessen, Deutschland Alvarez and Marsal Vollzeit

    Description A&M Financial Services Industry (FSI) revolves around core areas of expertise: Performance Improvement, Restructuring, Disruptive and Regulatory and Compliance (R&C) Advisory. A&M's dedicated Financial Services professionals work on some of the world's most high-profile cases in a rapidly transforming financial institution landscape, striving...

  • Director Private Debt

    vor 4 Wochen


    Frankfurt am Main, Deutschland Tikehau Investment Management - Annonces Vollzeit

    Tikehau Investment Management - Annonces Frankfurt am Main, GermanyPosted 3 hours ago Permanent Competitive - Director Private Debt - MISSIONS: - Playing a leading role in sourcing, evaluating and executing new investments in the DACH Private Debt market and working closely with the Private Debt team. - Along with other senior team members, contributing to...


  • Frankfurt Am Main, Deutschland BI International GmbH Vollzeit

    **Tasks & responsibilities**: - You will plan, coordinate, and oversee regulatory submissions required for maintenance of marketing authorizations in the EUCAN region. - In collaboration with other departments, you will organize, schedule, and lead a F2F or remote meetings with regulatory authorities in the EUCAN region. - You will proactively contribute as...

  • Director Private Debt

    vor 4 Wochen


    Frankfurt am Main, Deutschland Tikehau Investment Management - Annonces Vollzeit

    Director Private Debt MISSIONS: - Playing a leading role in sourcing, evaluating and executing new investments in the DACH Private Debt market and working closely with the Private Debt team. - Along with other senior team members, contributing to the development of investment strategies and adjusting strategies in relation to market changes. - Develop and...


  • Frankfurt am Main, Deutschland Proclinical Vollzeit

    Proclinical are recruiting an Associate Director Clinical Data Management - Germany for a biotech organisation. This role is on a permanent basis with the ability to work remotely from anywhere in Germany. *** **Responsibilities**: - Serve as a mentor for the new starters or possibly assign to suitable team members this action. - Offer constant feedback...


  • Frankfurt Am Main, Deutschland Viatris Vollzeit

    Mylan Germany GmbH At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life. We do so via: Access - Providing high quality trusted medicines regardless of...


  • Frankfurt am Main, Deutschland PrimeVigilance Vollzeit

    Company Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...


  • Schwalbach am Taunus, Deutschland Tempo-Team Personaldienstleistungen GmbH Vollzeit

    Unser Kunde, Konsumgüter am Standort Schwalbach, sucht zum nächstmöglichen Zeitpunkt eine(n) Regulatory Associate Researcher (Abteilung: Life Cycle) zunächst befristet auf 18 Monaten, mit der Option auf Übernahme.Unser Kunde, Konsumgüter am Standort Schwalbach, sucht zum nächstmöglichen Zeitpunkt eine(n) Regulatory Associate Researcher (Abteilung:...


  • Frankfurt, Deutschland Selby Jennings Vollzeit

    A leading global investment bank, with a notable presence spanning continents, are seeking an adept Legal & Compliance Director to strengthen their team in Frankfurt, Germany. Working collaboratively within the international Legal & Compliance team and alongside local counterparts, the successful candidate will assume a pivotal role in managing legal and...