(Senior) Expert Material Compliance

vor 6 Monaten

Frankfurt Am Main, Deutschland Fresenius Medical Care Vollzeit

**Main tasks**:
**_ Material compliance:_**:

- Evaluation of raw materials as well as finished products concerning regulatory EHS-requirements on substances and materials (REACH, POP, MDR, CLP, Packaging Directive etc.)
- Contact person to external supplier concerning the before mentioned requirements
- Creation and maintenance of dossiers for Nordic eco labeling (Nordic Swan)
- Support Registration/Regulatory Affairs and Product Center with required information regarding material compliance, e.g. Tender requests

**_ Value Stream and Development support activities:_**:

- Expert within cross functional teams concerning EHS material compliance and biocompatibility questions
- Support in second source and material change projects

**_ Biocompatibility/Toxicology:_**:

- Support Development of biocompatibility evaluation strategies
- Performance of safety and risk assessments for medical devices, based on the used raw materials, on extractable and leachable chemicals or on biocompatibility studies (ISO 10993-17)
- Biocompatibility Evaluations and Toxicological Expert statements
- Providing expert advice (e.g. expert statements)
- Acting as sponsor, study monitor and contact for chemical/biocompatibility studies in internal and external laboratories (creation of test plans and test reports)
- Compilation of overall biological safety assessment according to ISO 10993-1

**Secondary Tasks**:

- Support regulatory compliance, speed to market, reduction of risks to patients resulting in an increase in overall user satisfaction and enhanced regulatory compliance (as member of CFT or extended sub-teams).
- Support a Design Control approach and provide expertise to Value Streams and Q&R for compliance with applicable regulations (EU directive, local countries regulations).
- Close Collaboration regional as well as plant EHS departments and the central biocompatibility group
- Support Sustainability activities and internal and external audits

**Your Profile**:

- Scientific background (Masters degree) in Toxicology, Chemistry, Biology or Material Sciences or related fields
- Strong background in chemistry of medical polymers and materials used in contact with blood and the related analytical methods
- Experience of 2-3 years in Regulatory Affairs or Quality environment in pharmaceutical/medical field
- High identification with and loyalty to the department and the company
- Good and professional relationship to and communication with international colleagues and superiors.
- High engagement on achieving the targets and on the objectives of the position, proactive and solution-oriented approach towards problems, ability to work cross functional with all levels of employees
- Organizational capacity and analytical ability
- Autonomy in decision making
- Ability for a cross functional coordination
- Advanced knowledge of medical device risk management and related regulations
- Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 2017/745, MDSAP etc.)
- Advanced knowledge of applicable standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CFR -820.250, etc.)
- General knowledge of FDA 510(K) requirements
- Knowledge of internal and external processes and structures and of the (global) corporate Quality Management requirements
- Knowledge in statistical methods
- Experience in scientific writing
- English (fluent, very good knowledge)
- Required: Office (Excel/Word/Power Point, Outlook, Teams) Knowledge
- Additional: SAP, PDM systems as PTC Windchill, FMEA tools
- Independent working structure, hands on and ‘can do’ mentality
- Attitude to Team Work, ability to work in matrix environment
- Global mindset approach

  • Expert Material Compliance, Biocompatibility

    vor 6 Monaten

    Frankfurt Am Main, Deutschland Fresenius Medical Care Vollzeit

    **Main tasks**: **_ Material compliance:_**: - Evaluation of raw materials as well as finished products concerning regulatory EHS-requirements on substances and materials (REACH, POP, MDR, CLP, Packaging Directive etc.) - Contact person to external supplier concerning the before mentioned requirements - Creation and maintenance of dossiers for Nordic eco...

  • Senior Trade Compliance Expert

    vor 1 Woche

    Frankfurt am Main, Hessen, Deutschland SHEIN Vollzeit

    About SHEINSHEIN is a global fashion and lifestyle e-retailer committed to making the beauty of fashion accessible to all. We use on-demand manufacturing technology to connect suppliers to our agile supply chain, reducing inventory waste and enabling us to deliver a variety of affordable products to customers around the world.We are seeking a highly skilled...

  • Material Compliance Specialist for Biocompatibility Expertise

    Vor 3 Tagen

    Frankfurt am Main, Hessen, Deutschland Fresenius Medical Care Vollzeit

    Fresenius Medical Care is a leading global health care company committed to delivering the best possible care for individuals with renal diseases.Our team is dedicated to providing exceptional products and services that improve the quality of life for patients around the world.As a Material Compliance Specialist for Biocompatibility Expertise, you will play...

  • Compliance Expert for Risk and Regulatory Management

    vor 1 Woche

    Frankfurt am Main, Hessen, Deutschland Selby Jennings Vollzeit

    Job SummaryWe are seeking a seasoned Compliance Expert to join our team at Selby Jennings in Frankfurt. As Senior Compliance Manager, you will be responsible for ensuring regulatory adherence, designing compliance policies, and monitoring performance.This is a fantastic opportunity to leverage your expertise in risk management and regulatory compliance to...

  • Risk-Experte für Governance und Compliance

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland KPMG Vollzeit

    Rolle:Unser Team sucht einen erfahrenen Risiko- und Compliance-Experten, um unsere Mandanten bei der Konzeption, Implementierung oder Prüfung von Internen Kontrollsystemen, Risiko- oder Compliance Management Systemen zu unterstützen.Begleiten Sie unsere Kunden bei den zukünftigen Herausforderungen und machen gemeinsam mit uns den...

  • Senior Compliance Manager

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Michael Page Vollzeit

    Job SummaryWe are seeking a Senior Compliance Manager to join our team in ensuring the effective implementation and monitoring of Compliance Surveillance & Control plans.About the RoleManage Compliance Surveillance & Control plan and enhance the framework over time to cover relevant risks such as Money Laundering, Market Abuse, and/or the misuse of...

  • Senior Environmental Compliance Specialist

    vor 2 Wochen

    Frankfurt am Main, Hessen, Deutschland Silverback Staffing Limited Vollzeit

    Silverback Staffing Limited is seeking a highly skilled and experienced Senior Environmental Compliance Specialist to join our team in Frankfurt, Germany. The successful candidate will have a proven track record of ensuring compliance with local EHS regulations and company policies.Key Responsibilities:Develop and implement comprehensive EHS programs and...

  • Senior Compliance Spezialist für Risikomanagement

    Vor 6 Tagen

    Frankfurt am Main, Hessen, Deutschland Amadeus Fire AG Vollzeit

    Über unsFür ein erfolgreiches und wachsendes Unternehmen aus dem Bankensektor suchen wir in Festanstellung einen Senior Compliance Spezialisten (m/w/d) mit Schwerpunkt auf MaRisk und DORA.Wir legen großen Wert auf eine angenehme und respektvolle Unternehmenskultur. Der Senior Compliance Spezialist wird Teil des Erfolgskonzeptes und unterstützt unsere...

  • Senior AML-Experte mit direkter Verantwortung

    Vor 2 Tagen

    Frankfurt am Main, Hessen, Deutschland Michael Page Vollzeit

    Beruf: Senior AML-Experte mit direkter VerantwortungUnser Mandant, eine europäische renommierte Bank, sucht einen erfahrenen Senior AML-Experten mit direkter Berichtslinie an den MLRO/Head of Compliance.Kundendetails:Der Mandant ist ein führender Finanzdienstleister in Europa.Aufgaben und Verantwortungen:Implementierung von wirksamen Verfahren zur...

  • AML Compliance Expert

    Vor 4 Tagen

    Frankfurt am Main, Hessen, Deutschland Michael Page Vollzeit

    Deputy MLRO - Senior Manager AML/AFC Job DescriptionThe ideal candidate will support the Money Laundering Reporting Officer (MLRO) in managing the organization's Anti-Money Laundering/Countering the Financing of Terrorism (AML/CTF)/Anti-Financial Crime (AFC) program, ensuring statutory and regulatory compliance.Key Responsibilities:1. Support to the MLRO:...

  • Senior AML

    vor 1 Woche

    Frankfurt am Main, Deutschland Michael Page Vollzeit

    Senior AML & Compliance Spezialist (m/w/d)Unser Mandant sucht einen Senior AML & Compliance Speziali...

  • Senior Compliance Expert WpHG

    vor 4 Wochen

    Frankfurt am Main, Hessen, Deutschland Michael Page Vollzeit

    Beschreibung der PositionWir suchen einen erfahrenen Regulatorischen Fachmann für unsere Vermögensverwaltung. Die richtige Person wird sich für die Einhaltung regulatorischer Vorgaben und die Sicherstellung von Compliance im Bereich WpHG begeistern.AufgabenFunktion als Ansprechpartner für alle Compliance-, Geldwäsche- und...

  • Vp-compliance

    vor 7 Monaten

    Frankfurt am Main, Deutschland Moody's Vollzeit

    **Team/Department Description**: Moody's Compliance function operates globally to provide Compliance support, guidance and implementation to its business lines. This role is part of the EMEA Compliance team who are based out of London, Frankfurt, Paris, Dubai and Vilnius. The team is responsible for developing, implementing and administering the company's...

  • Deputy Compliance Officer

    vor 1 Woche

    Frankfurt am Main, Deutschland Michael Page Vollzeit

    Deputy Compliance Officer (m/w/d) Senior ManagerThe Senior Manager will act as the Deputy Compliance...

  • Deputy Compliance Officer

    Vor 7 Tagen

    Frankfurt am Main, Deutschland Michael Page Vollzeit

    Deputy Compliance Officer (m/w/d) Senior ManagerThe Senior Manager will act as the Deputy Compliance...

  • Senior Anti-Money Laundering Compliance Expert for Investment Banking

    vor 2 Wochen

    Frankfurt am Main, Hessen, Deutschland Hirschman Associates Vollzeit

    Experience the excitement of a leading financial institution with a global presence and a reputation for excellence in banking services.This top-tier bank is seeking a seasoned professional to join their team as an Anti-Financial Crime Compliance Manager (Associate Director) for Investment Banking.The ideal candidate will be responsible for developing and...

  • Compliance-Experte in Frankfurt am Main

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Fricke Finance & Legal Vollzeit

    Wir suchen einen motivierten und engagierten Compliance-Experten zum nächstmöglichen Zeitpunkt für unsere Kanzlei Fricke Finance & Legal in Frankfurt am Main.AufgabenDie Entwicklung, Aktualisierung und Durchführung interner Grundsätze, Verfahren und angemessener Sicherungssysteme zur Verhinderung der Geldwäsche, Terrorismusfinanzierung, der...

  • Procurement Expert for Recycled Materials

    vor 2 Wochen

    Frankfurt am Main, Hessen, Deutschland Astrantia Talent Vollzeit

    Astrantia Talent is a leading recruitment agency specializing in the global recycling industry.Position: Purchasing ManagerCompany Overview:This small enterprise prioritizes quality service and relationships with suppliers and clients.The goal is to treat partners as long-term business associates with a personalized approach. Their core strength lies in...

  • Rechtlicher Expert für Compliance-Fragen

    vor 3 Wochen

    Frankfurt am Main, Hessen, Deutschland Lufthansa Systems GmbH Vollzeit

    Bewirb Dich als Rechtlicher Expert für Compliance-Fragen bei Lufthansa Systems GmbH und trage zum Erfolg unserer Unternehmensgruppe bei.AufgabenDeine Aufgabe wird es sein, die Gestaltung, Implementierung und Einhaltung von Fremdpersonal-Compliance-Prozessen zu überwachen. Du berätst und unterstützt bei allen arbeitsrechlichen Fragestellungen in...

  • Senior Manager Compliance

    vor 4 Wochen

    Ingelheim am Rhein, Deutschland Boehringer Ingelheim Vollzeit

    At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after...