Regulatory Affairs Specialist - Endoscopy – Marlborough

Regulatory Affairs Specialist – Endoscopy – Marlborough, MA
Reports to Manager, Regulatory Affairs – Endoscopy

Delivering on the promise of medical innovation begins at Boston Scientific!

By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. Join a global organization that is fueled by the diversity and talent of its entire workforce.

Purpose/Role Statement

Responsible for Regulatory Affairs support of submissions and on going regulatory compliance for product development process.

Key Responsibilities

• 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.
  
  Qualifications
  
  
• Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline.
  
• 2 – 4 years Regulatory Affairs experience, medical industry experience preferred.
  
• Working knowledge of FDA and international regulations.
  
• General understanding of product development process and design control.
  
• General understanding of regulations applicable to the conduct of clinical trials.
  
• 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.
  Working Conditions*
  General office environment, with potential (domestic and international) travel to BSC facilities and other meetings
  
  *May not include all essential functions of the job such as all of the job’s physical/mental requirements
  
  
  Boston Scientific (NYSE: BSX) is a worldwide developer, manufacturer and marketer of medical devices with approximately 29,000 employees and revenue of $7.8 billion in 2006. For more than 25 years, Boston Scientific has advanced the practice of less-invasive medicine1 by providing a broad and deep portfolio of innovative products, technologies and services across a wide range of medical specialties. The Company’s products help physicians and other medical professionals improve their patients’ quality of life by providing alternatives to surgery. For more information, please visit .
  
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