Senior Manager Regulatory Affairs Design & Risk Management (m/f/d)

  • Ensure processes and products are appropriate, adequate, effective and in compliance with applicable quality standards and regulatory requirements according to global medical devices regulations
  • Lead all stages of the design development process for Medical Devices, including V&V, testing, design control and design change activities, ensuring quality assurance considerations and requirements are met
  • Ensure safe and effective medical devices are developed and designed in compliance with the regulatory requirements and QMS
  • Ensure that design projects comply with regulatory requirements and internal quality guidelines
  • Lead and support interdisciplinary teams (R&D, Production, Medical Affairs, Regulatory Affairs, Strategic Marketing) in implementation of risk management processes by moderating risk assessments, identifying sources of risks, conducting FMEAs and generating as well as maintaining the risk management files
  • Support Quality Systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives
  • Support relevant function in the generation of technical files
  • Support post-market surveillance activities
  • Contribute to and support Human Factors Engineering activities
  • Prepare presentations and management meetings
  • Successfully completed University degree in Engineering or related education
  • At least 5 years of professional experience in medical devices regulated companies in development and/or quality-related functions
  • Thorough knowledge of ISO 13485 and 9001 (Quality System) requirements, ISO 14971 (Risk Management), Medical Device Directives (MDD) and MDR requirements, knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
  • Professional and pro-active expert with a hands-on mentality and who has a seniority on Design and Quality-topics and project leadership
  • Ability to effectively lead projects/activities, design and drive change and make decisions
  • Technical and business competencies that drive results and continuous improvement
  • Excellent analytical, problem solving, and troubleshooting skills
  • Experience in working with interdisciplinary, multinational and virtual teams
  • Excellent communication skills to lead discussions with peers and senior management
  • Strong presentation skills as well as creative and out-of-the-box mindset
  • Fluent English language skills in speaking and writing
  • Very good skills in MS Office (Excel, PowerPoint, Word, Outlook)
  • Willingness to travel occasionally
  • Karrierelevel:
  • Berufserfahrene
  • Einsatzbereich:
  • Regulatory Affairs / Drug Safety / Qualitätsmanagement / Umwelt
  • Arbeitsverhältnis:
  • Unbefristet / Vollzeit
  • Unternehmensbereich:
  • Fresenius Kabi
  • Standort:
  • Hessen / Bad Homburg
  • Bewerbungsfrist:
  • none - we look forward to your application

Ihre Benefits

  • 05_Langzeitkonto
Erfahren Sie mehr über unser Angebot
Fabian Hörschelmann
Fresenius Kabi Deutschland GmbH
Oberursel
Ref. number: 42207

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

Senior Manager Regulatory Affairs Design & Risk Management (m/f/d)

Your assignments

  • Ensure processes and products are appropriate, adequate, effective and in compliance with applicable quality standards and regulatory requirements according to global medical devices regulations
  • Lead all stages of the design development process for Medical Devices, including V&V, testing, design control and design change activities, ensuring quality assurance considerations and requirements are met
  • Ensure safe and effective medical devices are developed and designed in compliance with the regulatory requirements and QMS
  • Ensure that design projects comply with regulatory requirements and internal quality guidelines
  • Lead and support interdisciplinary teams (R&D, Production, Medical Affairs, Regulatory Affairs, Strategic Marketing) in implementation of risk management processes by moderating risk assessments, identifying sources of risks, conducting FMEAs and generating as well as maintaining the risk management files
  • Support Quality Systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives
  • Support relevant function in the generation of technical files
  • Support post-market surveillance activities
  • Contribute to and support Human Factors Engineering activities
  • Prepare presentations and management meetings

Your profile

  • Successfully completed University degree in Engineering or related education
  • At least 5 years of professional experience in medical devices regulated companies in development and/or quality-related functions
  • Thorough knowledge of ISO 13485 and 9001 (Quality System) requirements, ISO 14971 (Risk Management), Medical Device Directives (MDD) and MDR requirements, knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
  • Professional and pro-active expert with a hands-on mentality and who has a seniority on Design and Quality-topics and project leadership
  • Ability to effectively lead projects/activities, design and drive change and make decisions
  • Technical and business competencies that drive results and continuous improvement
  • Excellent analytical, problem solving, and troubleshooting skills
  • Experience in working with interdisciplinary, multinational and virtual teams
  • Excellent communication skills to lead discussions with peers and senior management
  • Strong presentation skills as well as creative and out-of-the-box mindset
  • Fluent English language skills in speaking and writing
  • Very good skills in MS Office (Excel, PowerPoint, Word, Outlook)
  • Willingness to travel occasionally

Ihre Benefits

  • 05_Langzeitkonto
Erfahren Sie mehr über unser Angebot

Ihr Kontakt

Fabian Hörschelmann
Fresenius Kabi Deutschland GmbH
Oberursel
Ref. number: 42207

Karrierelevel
Berufserfahrene
Einsatzbereich
Regulatory Affairs / Drug Safety / Qualitätsmanagement / Umwelt
Arbeitsverhältnis
Unbefristet / Vollzeit
Unternehmensbereich
Fresenius Kabi
Standort
Hessen / Bad Homburg
Bewerbungsfrist
none - we look forward to your application

Offen für Individualität und Vielfalt

Fresenius begrüßt Bewerbungen aller Menschen, unabhängig von Geschlecht, Alter, Herkunft, Nationalität, Religion, Behinderung, sexueller Identität und Orientierung oder sonstigen Merkmalen.

Sämtliche Personenbezeichnungen in dieser Stellenausschreibung gelten für alle Geschlechter gleichermaßen (männlich, weiblich, divers).

Karriere mit Sinn

Mehr als 300.000 Menschen auf allen Kontinenten arbeiten bei Fresenius daran, immer bessere Medizin für immer mehr Menschen anzubieten. Unsere eigenständigen Unternehmens­bereiche Fresenius Medical Care, Fresenius Kabi, Fresenius Helios und Fresenius Vamed bieten ein breites Spektrum an Produkten und Dienstleistungen im Gesundheitssektor. Bei uns haben Sie die Chance, mit Ihrer Karriere einen Unterschied zu machen – und Teil unserer beeindruckenden Wachstumsgeschichte zu werden.

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