Abbott Laboratories
Location
Delkenheim, Wiesbaden | Germany
Job description
Regulatory Affairs Specialist DACH (m/f/d) page is loaded
Job Title
Regulatory Affairs Specialist DACH (m/f/d)
About Abbott
Abbott is a global health care leader , creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
In Germany, Abbott has more than 4 ,000 employees working in manufacturing, research and development, logistics , manufacturing, sales and marketing. They are located at Abbott`s German headquarters in Wiesbaden and its sites in Hanover, Neustadt am Rübenberge , Wetzlar , Eschborn , Cologne, Jena and Hamburg.
The Opportunity
This position works out of our Wiesbaden – Abbott GmbH location in the ADC Diabetes Care division. As the Regulatory Affairs Specialist DACH (m/f/d), you’ll have the chance to:
Primary Objective of Position
Support Regulatory & Quality Representative for Germany, Austria and Switzerland
Ensures organization meets existing and future internal and external regulatory and compliance standards.
Maintenance of the quality system to meet regulatory requirements and ISO 13485 requirements.
Ensures product communication, labeling & promotion material meets regulatory requirements.
Major Accountabilities
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
Drives critical improvements in compliance management analyzing changes in local regulatory framework.
Conducts regulatory trainings
Support of potential reportable events, medical events and field actions in close relation to customer service and vigilance groups.
Management of customer requests and complaints regarding MDR / IVDR regulatory issues
Regulatory review and approval of promotional material
Education
University Degree in Natural, Science, Medicine or Engineering
Professional Qualification
Fluent in English and German, written and oral
Background
EXPERIENCE REQUIRED:
Knowledge of regulatory requirements (e.g. MPG, MDR/IVDR), internal & external compliance regulations and quality standards
Initial project management experience
EXPERIENCE PREFERRED:
Regulatory, compliance and quality affairs of diagnostic, pharmaceutical or medical device industry
TECHNICAL SKILLS/TRAINING REQUIRED:
Organizational skills and high level of quality awareness
Standard Microsoft software applications
TECHNICAL SKILLS/TRAINING PREFERRED:
Organizational skills and high level of quality awareness
LEADERSHIP SKILLS:
Effective and motivating interpersonal communication skills
W orking at Abbott
At Abbott, you can do work that matters and help people to live a healthier and full life, grow your career, and learn, be your true self. You will have access to:
Career development with an international company where you can grow the career you dream of
An attractive benefits package ( e.g. attractive Abbott Pension Plan , stock purchase program)
A company r ecognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
A challenging position in a fast-growing crisis independent industry
To become part of a dynamic, highly educated, highly skilled, and motivated team
Flat hierarchies, open appreciative mentality, and efficient, constructive lines of communication
Multi-national environment, where we foster the development of our talents within the enterprise
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life . Abbott is an Equal Opportunity Employer, committed to employee diversity.
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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.
Connect with us at , on LinkedIn at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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