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Specialist I, Urology, Reg Affairs Job

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Date: Mar 8, 2019

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.

 

About the role:

At Boston Scientific, you’ll discover a place where you can find meaningful purpose, improving lives through your life's work.  The Urology and Pelvic Health business unit provides proven, leading solutions to treat five common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), male incontinence and pelvic floor disorders.

 

This position will be responsible for Regulatory Affairs support of submissions and on-going regulatory compliance.

 

Key Responsibilities:

  • Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
  • Reviews Technical Files for compliance with Essential Requirements and Corpoate SOP requirements; analyzes and initiates appropriate changes.
  • Provides technical/regulatory guidance to cross-functional integration teams.
  • 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.
  • Develops and implements regulatory strategies for products.
  • Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
  • Establishes and supports a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support.  Ensure employees are trained to do their work and their training is documented.

 

Qualifications:

  • Bachelor’s degree preferably in a scientific or technical discipline
  • 1+ years of reg affairs experience
  • General knowledge of FDA and international regulations
  • General understanding of product development process and design control
  • General knowledge of regulatory requirements for reusable and single use disposable devices.
  • 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

 

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: 440482

 


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