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Specialist II, Endoscopy, Regulatory Affairs Job

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Date: May 31, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

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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 the role: 

At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions with a focus on technologies for diagnosing and treating diseases of the digestive system, airway and lungs. We have a robust product portfolio of devices currently available for sale in the European Union (EU) which require transition to approval under the new EU Medical Device Regulation (MDR).  Boston Scientific is committed to ensuring continued availability of Endoscopy devices to patients in the EU. 


This role within Regulatory Affairs will provide dedicated and on-going support of activities required to obtain timely MDR approvals for Endoscopy devices.  With guidance from the Endo regulatory affairs management team this specialist will provide technical and administrative regulatory support to the ENDO MDR project team.    


Your responsibilities include:

  • Support BSC Endo RA EU MDR project lead in implementation of MDR requirements
  • Create and submit Technical Documentation to notified bodies for review
  • Prepare Declaration of Conformity Document for signature
  • Review and signs-off on product and manufacturing changes for compliance with EU MDR regulations
  • Review and sign off design documentation for compliance with EU MDR requirements
  • Participate as regulatory core team member on product specific MDR transition teams
  • Continuously assess ways to improve Quality
  • Supports efforts to improve collaboration, experience sharing and best practices within the department and division


What we're looking for:

Basic Qualifications

  • Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
  • 2 + years Regulatory Affairs or related experience, medical industry experience preferred.
  • Working knowledge of current and proposed EU regulations for medical devices, previous experience compiling technical files or design dossiers preferred
  • Familiar with ISO 13485 and MDSAP requirements
  • General understanding of product development process and design control
  • Ability to manage several projects simultaneously
  • Proficiency with Microsoft Office
  • Effective research and analytical skills
  • Effective written and oral communication, technical writing and editing skills
  • Ability to work independently with minimal supervision. In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
  • Good interpersonal skills
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy


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.


Requisition ID: 474496


Nearest Major Market: Boston

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