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Senior Specialist, Endoscopy, Regulatory Affairs Job

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Date: Mar 4, 2021

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.

 

 

Boston Scientific is a place where you can find meaningful purpose, improving lives through your work.  In the Endoscopy division, we develop and sell advanced technologies for diagnosing and treating diseases of the digestive system, airway, and lungs.  Our robust product portfolio provides a variety of devices and solutions  that include focus in the areas of single-use imaging, luminal patency, hemostasis, infection prevention, core gastro-intestinal, and biliary.  We continue to innovate and make investments in Endoscopy treatments, both within established product lines as well as in future pipelines.

 

About the role:

The Senior Regulatory Affairs Specialist will provide regulatory support on a range of Endoscopy devices and activities which include new product introduction, evaluation of post market design changes, international submission support, commercial, manufacturing, & compliance support as well as other responsibilities aligned with global medical device regulations and goals of the business.

 

Key responsibilities include:

  • Act as company representative under minimal supervision, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, and submission review
  • Research, develop, and implement regulatory strategies for new and modified medical devices
  • Represent Regulatory Affairs on in development core teams, providing Regulatory feedback and guidance throughout the product development cycle
  • Prepare and submit regulatory documentation and applications
  • Review device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes
  • Review and approve product and manufacturing changes for compliance with regulatory requirements
  • Support and maintain Quality initiatives in accordance with BSC Quality Policy
  • Continuously assess ways to improve Quality

 

What we’re looking for:

Basic qualifications:

  • Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
  • 5 + years Regulatory Affairs experience, medical device industry experience required
  • 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 manage several projects of moderate scope and complexity simultaneously
  • Proficiency with Microsoft Office
  • Effective research, analytical, and problem-solving 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 – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

 

Requisition ID: 474490

 


Nearest Major Market: Boston

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