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
  • Career level:
  • Professional Experienced / Graduates
  • Job function:
  • Regulatory Affairs / Drug Safety / Quality Management / Environment
  • Working condition:
  • Permanent / Full-time
  • Business segment:
  • Fresenius Kabi
  • Location:
  • Hessen / Bad Homburg
  • Closing date for applications:
  • keine - Wir freuen uns auf Ihre Bewerbung

Your Benefits

  • 05_Langzeitkonto
Learn more about what we offer
Fabian Hörschelmann
Fresenius Kabi Deutschland GmbH
Oberursel
Kennziffer 42209

We welcome diversity

At Fresenius all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics.

All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse).

Career with a purpose

Over 300,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.

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

Your Benefits

  • 05_Langzeitkonto
Learn more about what we offer

Your contact

Fabian Hörschelmann
Fresenius Kabi Deutschland GmbH
Oberursel
Kennziffer 42209

Career level
Professional Experienced / Graduates
Job function
Regulatory Affairs / Drug Safety / Quality Management / Environment
Working condition
Permanent / Full-time
Business segment
Fresenius Kabi
Location
Hessen / Bad Homburg
Closing date for applications
keine - Wir freuen uns auf Ihre Bewerbung

We welcome diversity

At Fresenius all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics.

All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse).

Career with a purpose

Over 300,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.

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