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Specialist II, Endoscopy, Regulatory Affairs Job

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Date: Sep 13, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations:

 

 

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. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. In the Endoscopy division, we provide advance technologies for diagnosing and treating diseases of the digestive system, airway and lungs. Medical Conditions we provide solutions for include: Malignant & Benign Tumors, Gastrointestinal Diseases, Pulmonary Diseases, Gastrointestinal Cancers and Abscesses. We are able to provide a number of solutions to patients that include: Balloon Dilation, Stenting, ERCP/Cholangioscopy, Biliary, Biopsy and Polypectomy, Hemostasis, and Enteral Feeding.  We have a robust product portfolio and pipeline, and Boston Scientific is committed to continued investment in the Endoscopy business. Responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development process and sustaining engineering projects.

 

Your responsibilities include:

  • Act 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 and manufacturing process 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.
  • 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 FDA, EU 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.
  • 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.
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.

 

 

 

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: 481067

 


Nearest Major Market: Boston

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