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Project Manager I, EU MDR Job

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Date: Apr 19, 2019

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: (n/a)

 

 

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.

 

Project Manager I, EU MDR 

 

About this role:

This is a critical leadership role working to drive and maintain compliance of Marlborough Quality Systems to the requirements of EU MDR.

Provides focused direction to Quality Systems and other cross-functional teams on EU MDR requirements and drives adoption of EU MDR compliant processes. Works with divisional EU MDR project managers to ensure a cadence of product family updates to ensure EU MDR compliance prior to May 2020. Liaise with cross functional groups to ensure post market surveillance activities are planned and executed to ensure compliance with EU MDR. Remediate any Quality System gaps identified in ongoing EU MDR gap assessments and internal audits. Serves as a Quality representative to improve awareness, visibility, and communication on EU MDR compliance/progress to support departmental, functional, site, divisional and corporate quality goals and priorities.

 

Your responsibilities include:

  • Planning for EU MDR implementation across the Endoscopy and Urology & Pelvic Health divisions.
  • Coordination of planning and implementation activities associated with EU MDR compliance.
  • Engage cross-functional groups to agree appropriate cadence to coordinate and complete remediation activities.
  • Highlight resource or other constraints which are encountered during the transition to EU MDR compliance. 
  • Communicating performance of both divisions against their EU MDR implementation plans at regular review meetings.
  • Ensure timely and appropriate implementation of relevant corrective or preventive actions.
  • Communicate EU MDR requirements effectively to personnel.
  • Provides guidance to Quality and other personnel in interpretation of EU MDR requirements.
  • Reviews, understands, and implements Global and divisional updates related to EU MDR implementation.
  • Reporting to senior management on EU MDR implementation progress.

 

What we’re looking for in you:

Minimum Qualifications

  • 5-8 years’ experience in Quality with a Bachelor’s degree Engineering or related technical discipline.
  • Excellent written and verbal communication skills
  • Working knowledge and understanding of EU MDR and other medical device industry quality requirements.
  • Ability to develop and maintain detailed project plans
  • Demonstrated ability to identify and work with cross functional organizations to solve problems
  • Strong command of MS Office – Word, Excel, Powerpoint, Visio
  • Ability to rapidly learn and use new applications

 

Preferred Qualifications

  • Previous experience in Quality Assurance, Quality Engineering or Quality Systems background.
  • Experience in the medical device industry
  • Working knowledge of EU MDR.
  • Experience in managing projects and managing a cross-functional team

 

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: 443667

 


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