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Regulatory Documentation Control Specialist I Job

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Date: Sep 15, 2021

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

Additional Locations:

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About This Role:
This Regulatory Documentation Control Specialist I position will provide Windchill, SAP, DOCS, and eRelease support both transactionally and by supporting new and existing users of these systems. Direct support of system users to resolve issues they encounter will be required. As a Specialist I position, coaching to develop some of the system specific skills needed for this role is expected. 

This position will primarily support Maple Grove Documentation Services but will also be cross trained to support Post Production Quality Assurance. 
 

Your Responsibilities Will Include:

  • Provide administrative support to own department on a timely and accurate basis.
  • Provide documentation and change management support on a timely and accurate basis which could include but not limited to creating and managing objects, change notices and change tasks under guidance of others.
  • Apply BSC data management tools (Windchill and SAP).
  • Apply concepts from BSC Doc Control Policies and Procedures.
  • Basic understanding of applicable internal procedures.
  • Assist in gathering change metrics and providing reports as required.
  • Interpret and implement global/Corporate documentation requirements as they relate to local documentation requirements with guidance of others.
  • Provide support for new and/or existing Windchill users.
  • Participate in specific projects under the guidance of others.
  • Support post production quality assurrance product release, as needed

 

What We’re Looking For In You:
Minimum Qualifications

  • High School graduate or GED 
  • Familiarity with BSC’s Quality System and ISO 14385 or equivalent
  • Team mentality and demonstrate flexibility in handling completing demands
  • Good verbal and written communication skills, 
  • Attention to detail
  • Continuous improvement mindset with a passion for Quality

 

Preferred Qualifications

  • Experience with Windchill or SAP
  • Experience in processing NCEP/CAPA 
  • Experience with Excel, SharePoint/Teams
     

 

Requisition ID: 497296

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

 

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

 


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