Job Details

Manager (m/f/d) Medical Device & Drug

Bad Homburg, Hessen, Deutschland

Fresenius Medical Care Deutschland GmbH

Englisch Promotion Fachhochschulstudium Universitätsstudium

Beschäfti­gungsart

Beschäftigungsverhältnis
Festanstellung
Befristung
unbefristet
Arbeitszeit
vollzeit
Home Office
nein

Beschreibung

 

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CAREER WITH A PURPOSE

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Fresenius Medical Care - Creating a future worth living. For patients. Worldwide. Every day. More than four decades of experience in dialysis, innovative research, the global leader in dialysis services and products - that is Fresenius Medical Care.
freseniusmedicalcare.com

(2x) Manager (m/w/d) Medical Device & Drug

As a Manager (m/f/d) Medical Device & Drug, you will render support in complying with the requirements of the Fresenius Medical Care quality management system and internal quality assurance measures. You will be responsible for supplier maintenance such as distributors, contract manufacturers, wholesalers and critical service providers within the framework of Medical Device QMS / RA & Drug GxP Systems.

More


As a Manager (m/f/d) Medical Device & Drug, you will render support in complying with the requirements of the Fresenius Medical Care quality management system and internal quality assurance measures. You will be responsible for supplier maintenance such as distributors, contract manufacturers, wholesalers and critical service providers within the framework of Medical Device QMS / RA & Drug GxP Systems.

Ihre Aufgabe


You will draft, update and maintain quality assurance agreements in accordance with regulatory and statutory obligations (AMWHV, AMG, MDD/MDR, AM-HandelsV) as well as the operational obligations such as coordination of SOPs, validations, drafting of documents with distributors, contract manufacturers, wholesalers and service providers. Maintenance and administration of a contract management database will also be a part of your daily doing as well as initiating and following-up on measures to qualify and support distributors, pharmaceutical wholesalers, suppliers and critical service providers. You will conduct internal audits as well as external audits for service providers, e.g. warehouses, contract manufacturers or contract laboratories. While preparing and monitoring annual audit plans according to Medical Device and Medicinal Products regulations within the department, you will render support in the implementation quality assurance measures, of applicable legal requirements and of service agreements.

Ihr Profil


You have a university degree in natural sciences or equivalent and have expertise in the field of Medical Devices/ MDD / MDR / Quality Management Systems (ISO 9001/13485) / GxP. Experience in the field of drug and medical device law is a core requirement that you can easily fulfill.

On a personality level, you will convince us if you have a goal- and process-oriented approach and can demonstrate high degree of conscientiousness and discretion. Your ability to work in a team as well as in an intercultural community goes without saying. Demonstrating your strong communication skills when communicating across all business areas is something you enjoy doing.

Furthermore, we would truly appreciate your application if you are eager to use your German and English language skills (spoken and written). Your willingness to travel within the scope of projects and external audits is clearly given.

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At a glance


Career level:


Professional Experienced


Job category:


Quality Management / Environment, Regulatory Affairs / Drug Safety

Working condition:


Permanent contract / Full-time

Business segment:


Fresenius Medical Care


Location:


Bad Homburg / Hessen

Closing date for applications:

keine - Wir freuen uns auf Ihre Bewerbung

Apply now


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Your contact

Yvonne Illie

Fresenius Medical Care Deutschland GmbH
Bad Homburg
Kennziffer 32474

About Fresenius

Career with a purpose:


Over 270,000 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.

career.fresenius.com

fresenius.com

 

One of Fresenius' strengths:

our corporate culture for «entrepreneurs in an enterprise» where you can quickly take on responsibility.

More reasons

 

The benefits we offer:


Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs.

More benefits


Your contact


Yvonne Illie
Fresenius Medical Care Deutschland GmbH
Bad Homburg
Kennziffer 32474

career.fmc-ag.com

Career level:


Professional Experienced

Job category:


Quality Management / Environment, Regulatory Affairs / Drug Safety

Working condition:


Permanent contract / Full-time

Business segment:


Fresenius Medical Care

Location:


Bad Homburg / Hessen

Closing date for applications:

keine - Wir freuen uns auf Ihre Bewerbung

About Fresenius


Over 270,000 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.

career.fresenius.com

fresenius.com

One of Fresenius' strengths:

our corporate culture for «entrepreneurs in an enterprise» where you can quickly take on responsibility.

More reasons


The benefits we offer:


Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs.

More benefits