Regulatory Affairs Specialist DACH (m/f/d)

Job description

JOB DESCRIPTION:

Job Title  

Regulatory Affairs Specialist DACH (m/f/d)  

About Abbott  

Abbott is a global healthcare 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   

Abbott Diabetes Care division is looking for a 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

Working 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 recognized 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. 

#earlycareers 

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 www.abbott.com , on LinkedIn at https://www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. 

     

The base pay for this position is
N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ADC Diabetes Care

        

LOCATION:

Germany > Wiesbaden-Delkenheim : G20

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable