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Product Compliance Expert, Quality, BPS

Bohemia, NY 11716, USA, Virtual Req #421
Monday, July 22, 2019

Our products enable the biopharmaceutical industry to be at the forefront in the development and advancement of treatments for serious diseases. Earning sales revenue of more than 1.4 billion in 2017 our people come from over 60 nations at 50 sites in 33 countries.

 

What you can look forward to accomplishing:

  • Analysis and surveillance of global regulatory and normative requirements for electrical devices and Mechanical regulations

  • Identify regulations required in different countries as required by Sartorius and proactively monitor these regulations

  • Analysis and improvement of existing procedures, processes and systems for fulfilling regulatory requirements.

  • Establishing new processes required for fulfilling regulatory requirements

  • Preparation and implementation of regulatory changes in the company and give trainings if required

  • Communication with international authorities, notified bodies and test laboratories

  • Communication with suppliers, customers, and external service providers, e.g. laboratories

  • Creating and maintaining regulatory documentation

  • Creating Declarations of Compliance and certificates/statements

  • Signing and reviewing CE marking declarations for electrical safety

     

Skills and experience that you need to bring to our company:

  • Successfully completed degree in science or technical related field, e.g. electrical engineering

  • At least 3 years of practical experience in regulatory affairs or quality, preferably for electrical instruments

  • Knowledge of global regulatory requirements for electrical instruments, e.g. Electrical Safety, Machine Safety, Electrical Compatibility (EMC).

  • Knowledge of global mechanical regulations, e.g. machine safety, pressurized equipment. Physical agents (noise uV etc.)

  • Strong identification with our core values: Sustainability, Openness, Enjoyment

 

Driving our future growth requires talented people. Sartorius is a dynamic organization suited to people who want to showcase skills, be recognized for expertise and thrive in a vibrant and innovative environment.


All qualified applicants will receive consideration for employment without regard to race, color, religion, sex or national origin.  We are also an equal opportunity employer of individuals with disabilities and protected veterans. 

Please view equal employment opportunity posters provided by OFCCP here
 

https://e-verify.uscis.gov/esp/media/resourcesContents/EverifyPosterEnglish.pdf
 

https://e-verify.uscis.gov/esp/media/resourcesContents/EverifyPosterSpanish.pdf
 

https://e-verify.uscis.gov/esp/media/resourcesContents/WebBPPOSTERRtoWEnglishversion.pdf
 

https://e-verify.uscis.gov/esp/media/resourcesContents/WebBPPOSTERRtoWSpanishversion.pdf

  • Bohemia, NY 11716, USA
  • Virtual