Regulatory Document Control Specialist I - Defined Term Job

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

 

About This Role:

This role is within the Quality function of acquired company NxThera and will be supporting ongoing run-the-business activities at NxThera as the company integrates into the Urology & Pelvic Health division of Boston Scientific Corporation (BSC).

Primary responsibilities:

  • Maintains and implements change management system in support of quality systems and practices to meet NxThera / BSC, customer and regulatory requirements.
  • Maintains training records and other paper-based quality records
  • Supports implementation of BSC integration changes affecting NxThera Quality System
  • Supports transition from NxThera Quality System to BSC Quality System

*Note that the position initially will be located at NxThera’s location in Maple Grove MN and then will move to BSC site in Arden Hills MN.*

 

 

Your Responsibilities Will Include:

  • Provide administrative support to own department on a timely and accurate basis.
  • Provide documentation and change management support as required.
  • Document Change Request (DCR) Process: Using NxThera Grand Avenue system, process DCR through various stages of the DCR process. 
  • DCR Management: prioritize requests for urgent DCRs; communicate DCR issues with applicable individuals; ensures DCRs are processed in a timely manner; ensure DCRs comply with company procedures.
  • Participates in specific projects under the guidance of others.
  • Assists in gathering change metrics and providing reports as required.
  • Other duties as assigned that support NxThera Quality System requirements
  • Other duties as assigned that support integration of the BSC Quality System

 

 

What We’re Looking For In You:

Minimum Qualifications

  • AA Degree or equivalent work experience in related discipline.
  • Experience using electronic document management system
  • Experience working in medical device industry or other regulated industry
  • Ability to prioritize tasks to meet business demands
  • Good communication skills both verbally and written
  • Collaboration skills with teams to achieve project team deliverables

Preferred Qualifications

  • Experience using Grand Avenue document management system and/or Windchill PLM system
  • Demonstrated ability to work effectively in an organization undergoing significant change

 

 

 

About Us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 436547

 

Company
Boston Scientific
Posted
09/20/2018
Type
Full time
Location
Maple Grove, MN 55311, US