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

61348 Bad Homburg
16.04.2019

Daten dieser Anzeige

Job-ID: 010062837
Manager (m/f/d) Medical Device & Drug

Fresenius Medical Care Deutschland GmbH

Germany

https://karriere.fresenius.de/de/job_application/3852982/apply

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.

  / CAREER WITH A PURPOSE / 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 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. Apply now Send via email Print this page 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 Send via email Print this page Your contact 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 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

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Medizintechnik/ Optik

Gesundheits-/ Sozialwesen/ Medizin

Angestellter/ Fachkraft

Vollzeit

61348 Bad Homburg