Manager Regulatory Affairs (m/f/d)

  • Update and maintenance of the technical documentation for irrigation solutions in line with current legal requirements (e.g. MDD 93/42, MDR 2017/45, ISO 13485) and internal SOPs
  • Coordination of the production units with regards to update and harmonization of the annexes to the technical documentation
  • Leading role in definition of common templates for annexes to the technical documentation
  • Act as an expert for all questions related to the technical documentation for internal stakeholders (e.g. marketing, productions units, supply chain)
  • Assure compliance of label and IFU with legal requirements and initiate respective label updates
  • Responsible for oversight in all applicable standards and assure state of the art of relevant standards for irrigation solutions
  • Close interaction with design functions and marketing
  • Key contact for the implementation of document management system for irrigation solutions
  • Provision of documents for registration of irrigation solutions in non EU countries
  • Support requests from local affiliates on the medical device portfolio of the Business Unit
  • Use of regulatory affairs database (RegTrack)
  • Provision of information to Eudamed
  • Participation in internal and external audits for all topics related to the technical documentation
  • Support of post-market surveillance activities and clinical evaluation
  • Monitoring the regulatory surrounding, by e.g. checking the authority websites for new guidance documents
  • Monitoring the changes in legislation/updates
  • Provide regulatory support to other departments, e.g. SCM, Marketing
  • Being a project team member in development projects for combination products
  • Successfully completed university degree in Medical Engineering, Life Sciences, Medicine, Pharmacy or related fields
  • 4 or more years of professional experience in the field regulatory affairs for Medical Devices
  • Scientific and technical experience for Medical Device development and life cycle management
  • Basic knowledge in regulatory affairs for Pharmaceuticals
  • Well-organized, team-minded, solution oriented way of working
  • Good communications skills to work in a interdisciplinary, multi-national and virtual team
  • Thorough knowledge of ISO 13485, requirements, ISO 14971 (Risk Management), Medical Device Directives (MDD) and Medical Device Regulation (MDR) requirements, knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
  • Good knowledge in MS Office and general affinity to work with electronic systems
  • Willingness to continuously develop regulatory expertise and areas
  • Fluent in English and German, knowledge of another foreign language desirable
  • Strong communication and presentation skills
  • Ability to adapt to changing circumstances
  • Experience in intercultural project teams
  • Willingness to travel occasionally
  • Karrierelevel:
  • Berufserfahrene / Berufseinsteiger
  • Einsatzbereich:
  • Regulatory Affairs / Drug Safety / Qualitätsmanagement / Umwelt
  • Arbeitsverhältnis:
  • Unbefristet / Vollzeit
  • Unternehmensbereich:
  • Fresenius Kabi
  • Standort:
  • Hessen / Bad Homburg
  • Bewerbungsfrist:
  • keine - Wir freuen uns auf Ihre Bewerbung

Ihre Benefits

  • 05_Langzeitkonto
Erfahren Sie mehr über unser Angebot
Fabian Hörschelmann
Fresenius Kabi Deutschland GmbH
Oberursel
Kennziffer 42209

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.

Manager Regulatory Affairs (m/f/d)

Job description

  • Update and maintenance of the technical documentation for irrigation solutions in line with current legal requirements (e.g. MDD 93/42, MDR 2017/45, ISO 13485) and internal SOPs
  • Coordination of the production units with regards to update and harmonization of the annexes to the technical documentation
  • Leading role in definition of common templates for annexes to the technical documentation
  • Act as an expert for all questions related to the technical documentation for internal stakeholders (e.g. marketing, productions units, supply chain)
  • Assure compliance of label and IFU with legal requirements and initiate respective label updates
  • Responsible for oversight in all applicable standards and assure state of the art of relevant standards for irrigation solutions
  • Close interaction with design functions and marketing
  • Key contact for the implementation of document management system for irrigation solutions
  • Provision of documents for registration of irrigation solutions in non EU countries
  • Support requests from local affiliates on the medical device portfolio of the Business Unit
  • Use of regulatory affairs database (RegTrack)
  • Provision of information to Eudamed
  • Participation in internal and external audits for all topics related to the technical documentation
  • Support of post-market surveillance activities and clinical evaluation
  • Monitoring the regulatory surrounding, by e.g. checking the authority websites for new guidance documents
  • Monitoring the changes in legislation/updates
  • Provide regulatory support to other departments, e.g. SCM, Marketing
  • Being a project team member in development projects for combination products

Job requirements

  • Successfully completed university degree in Medical Engineering, Life Sciences, Medicine, Pharmacy or related fields
  • 4 or more years of professional experience in the field regulatory affairs for Medical Devices
  • Scientific and technical experience for Medical Device development and life cycle management
  • Basic knowledge in regulatory affairs for Pharmaceuticals
  • Well-organized, team-minded, solution oriented way of working
  • Good communications skills to work in a interdisciplinary, multi-national and virtual team
  • Thorough knowledge of ISO 13485, requirements, ISO 14971 (Risk Management), Medical Device Directives (MDD) and Medical Device Regulation (MDR) requirements, knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards
  • Good knowledge in MS Office and general affinity to work with electronic systems
  • Willingness to continuously develop regulatory expertise and areas
  • Fluent in English and German, knowledge of another foreign language desirable
  • Strong communication and presentation skills
  • Ability to adapt to changing circumstances
  • Experience in intercultural project teams
  • Willingness to travel occasionally

Ihre Benefits

  • 05_Langzeitkonto
Erfahren Sie mehr über unser Angebot

Ihr Kontakt

Fabian Hörschelmann
Fresenius Kabi Deutschland GmbH
Oberursel
Kennziffer 42209

Karrierelevel
Berufserfahrene / Berufseinsteiger
Einsatzbereich
Regulatory Affairs / Drug Safety / Qualitätsmanagement / Umwelt
Arbeitsverhältnis
Unbefristet / Vollzeit
Unternehmensbereich
Fresenius Kabi
Standort
Hessen / Bad Homburg
Bewerbungsfrist
keine - Wir freuen uns auf Ihre Bewerbung

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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