Job Details

(Junior) Manager (m/f/d) Medical Device Vigilance

Bad Homburg, Hessen, Deutschland

Fresenius Medical Care Deutschland GmbH

Englisch Universitätsstudium Fachhochschulstudium

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

(Junior) Manager (m/f/d) Medical Device Vigilance

Within Fresenius Medical Care, the QREM Department (Quality, Regulatory Affairs & Management Systems) has the key responsibility to ensure that the company maintains and receives its marketing authorizations (e.g. CE-marks or drug registrations). Having identified legal requirements and regulations for the company, QREM works with different departments guiding them and ensuring that regulatory compliance and regulatory prerequisites for medical devices & drugs are met. Within the company, QREM holds different regulatory functions and one lies within Drug Regulatory Affairs & Product Safety.

More


Within Fresenius Medical Care, the QREM Department (Quality, Regulatory Affairs & Management Systems) has the key responsibility to ensure that the company maintains and receives its marketing authorizations (e.g. CE-marks or drug registrations). Having identified legal requirements and regulations for the company, QREM works with different departments guiding them and ensuring that regulatory compliance and regulatory prerequisites for medical devices & drugs are met. Within the company, QREM holds different regulatory functions and one lies within Drug Regulatory Affairs & Product Safety.

Your assignments


As a "(Junior) Manager (m/f/d) Medical Device Vigilance" you will make an important contribution to the safety of our medical devices. You will record and document medical device risks and will identify and document product safety indicators, create post market surveillance & periodic safety update reports and process product incidents.

Your task will also include recording and documenting of risks concerning medical devices. While reporting medical device incidents to the authorities, you will compile risks of medical devices for clinical evaluation and will draft product safety indicators.

Process optimization for vigilance of medical devices and maintenance of security databases will be part of your responsibility.

Your profile


If you have a graduate degree in technical or scientific studies or equivalent qualification with relevant experience in a similar function then you would be on the right track. We would surely appreciate your application if you have professional expertise in EU medical devices law (incl. MEDDEV guidelines) and experience in Management System Standards (ISO 13485, ISO 14971).

If you enjoy using your analytical, evaluation and decision-making skills then this position would be worth your while.

On a personal level, you would convince us if you are keen on demonstrating your strong communication and conflict management competence and if you capable of handling confidential information and of interacting across all levels of business functions. In this role as a "(Junior) Manager (m/f/d) Medical Device Vigilance, we expect you to have high language proficiency in German and English (written and spoken) to interact within our international working environment.

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At a glance


Career level:


Professional Experienced , Graduates

Job category:


Regulatory Affairs / Drug Safety

Working condition:


Permanent contract / Full-time

Business segment:


Fresenius Medical Care


Location:


Bad Homburg / Hessen

Closing date for applications:

none - we look forward to your application

Apply now


Send via email

Print this page


Your contact

Fresenius Medical Care Deutschland GmbH

Bad Homburg
Ref. number: 31700

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

Fresenius Medical Care Deutschland GmbH

Bad Homburg
Ref. number: 31700

career.fmc-ag.com

Career level:


Professional Experienced , Graduates

Job category:


Regulatory Affairs / Drug Safety

Working condition:


Permanent contract / Full-time

Business segment:


Fresenius Medical Care

Location:


Bad Homburg / Hessen

Closing date for applications:

none - we look forward to your application

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