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Principal Specialist, Regulatory Affairs - Endoscopy Job

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Date: Oct 16, 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, this is a place where you can find meaningful purpose, improving lives through your life's work.  In the Endoscopy division, we provide advance technologies for diagnosing and treating diseases of the digestive system, airway and lungs. We have a robust product line and pipeline, and we will continue to make an investment in Endoscopy treatments.  This role in Regulatory Affairs will be responsible for support of submissions and on-going regulatory compliance for the product development process.

Your responsibilities include:

  • Under minimal supervision, acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
  • Assists with developing and implementing regulatory strategies for new and modified medical devices
  • Acts as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
  • Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation.
  • Reviews device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.
  • Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
  • Support and maintain Quality initiatives in accordance with BSC Quality Policy.
  • Continuously assess ways to improve Quality.


What we're looking for in you:

Required qualifications:

  • A minimum of a Bachelor’s degree in a scientific, technical, or related discipline
  • A minimum of 8 years Regulatory Affairs experience in the medical industry
  • Prior experience with 510K submissions 
  • Prior experience with Class III devices
  • Working knowledge of FDA and international regulations for medical devices.
  • General understanding of product development process and design control.
  • General understanding of regulations applicable to the conduct of clinical trials.


Preferred qualifications:

  • Ability to simultaneously manage several projects.
  • 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.


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


Requisition ID: 497736


Nearest Major Market: Boston

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