Junior Manager Regulatory Affairs, Quality & Compliance, ADC, DACH (m/f/d)

65183 Wiesbaden
09.04.2021

Daten dieser Anzeige

Job-ID: 021134494
Junior Manager Regulatory Affairs, Quality & Compliance, ADC, DACH (m/f/d)

Abbott GmbH

Germany

https://www.jobs.abbott/global/de/apply/1/1?jobSeqNo=ABLAUS30978329DEGLOBALEXTERNAL&utm_campaign=jobware&utm_source=jobware&utm_medium=jobware

Supervision, evolution and tracking of Quality System (DIN ISO standard 13485). Establishment and implementation of divisional and local quality procedures according to internal and external regulatory standards Ensure that ADC meets local compliance standards of Environmental, Health & Safety (EHS), Affiliate Compliance Committee (ACC) requirements and other legal requirements. Drives critical improvements in compliance management analyzing changes in local regulatory framework. Acts as training coordinator for ADC Germany, Austria and Switzerland. Conducts quality, regulatory & compliance trainings Conduct Management Reviews Conducts internal and external audits at affiliate sites and suppliers in Germany, Austria and Switzerland as necessary Support of potential reportable events, medical events and field actions in close relation to customer service and vigilance groups. Management of customer requests regarding quality or regulatory related issues Regulatory review and approval of promotional material Supports management of business critical potential reportable events, medical events and field actions TRAVEL: Approximately 10-15%

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries. In Germany, Abbott has more than 3,000 employees working in manufacturing, research and development, logistics, sales and marketing. They are located at Abbott's German headquarters in Wiesbaden and its sites in Hanover, Neustadt am Rübenberge, Wetzlar, Eschborn, Witten, Cologne and Jena. Abbott Automation Solutions in Hamburg (formerly GLP Systems) is now Abbott. Abbott Diabetes Care (ADC) Division is looking for a Junior Manager Regulatory Affairs, Quality & Compliance, ADC, DACH (m/f/d) Main Responsibilities: Supervision, evolution and tracking of Quality System (DIN ISO standard 13485). Establishment and implementation of divisional and local quality procedures according to internal and external regulatory standards Ensure that ADC meets local compliance standards of Environmental, Health & Safety (EHS), Affiliate Compliance Committee (ACC) requirements and other legal requirements. Drives critical improvements in compliance management analyzing changes in local regulatory framework. Acts as training coordinator for ADC Germany, Austria and Switzerland. Conducts quality, regulatory & compliance trainings Conduct Management Reviews Conducts internal and external audits at affiliate sites and suppliers in Germany, Austria and Switzerland as necessary Support of potential reportable events, medical events and field actions in close relation to customer service and vigilance groups. Management of customer requests regarding quality or regulatory related issues Regulatory review and approval of promotional material Supports management of business critical potential reportable events, medical events and field actions TRAVEL: Approximately 10-15% Your Qualification: University Degree in Natural Sciences, Medicine or Engineering Professional Qualification Fluent in English and German, written and oral Knowledge of regulatory requirements (e.g. MPG, MDR/IVDR), internal & external compliance regulations and quality standards Initial project management experience Organizational skills and high level of quality awareness Standard Microsoft software applications Effective and motivating interpersonal communication skills Abbott Germany has a range and variety of jobs on offer in a positive and dynamic environment that allows you to maintain a healthy work-life balance. We provide development opportunities as part of our comprehensive Talent Management Program. Your contribution to the company's success will be rewarded with a competitive salary package. We offer comprehensive benefits to suit the lifestyles of all our employees, from a retirement plan that is far above market average, a save-as-you-earn program, to educational scholarships for children, and health management initiatives for staff and their dependents. Do you like the sound of this job and think you've got what it takes? Then send us your CV today. We look forward to receiving your application. Apply now. Discover why candidates choose a career with Abbott in Germany. AN EQUAL OPPORTUNITY EMPLOYER - Abbott welcomes and encourages diversity in our workforce We ask for your understanding that we only consider online applications via our online application portal. Applications by email or post cannot be processed. Original documents will not be returned.

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Technische Berufe/ Fertigung/ Produktion

Ingenieurwesen

Chemie/ Pharma/ Biotechnologie

Medizintechnik/ Optik

Angestellter/ Fachkraft

Vollzeit

65183 Wiesbaden