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Specialist II, Urology, Reg Affairs Job

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Date: Nov 23, 2018

Location: San Jose, CA, US, 95101

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.

 

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. The American Medical Systems (AMS) business of Boston Scientific includes Men’s Health and Prostrate Health for treatment of urologic conditions, including benign prostatic hyperplasia (BPH), male stress urinary incontinence and erectile dysfunction. 

 

Job Purpose:

Responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development and manufacturing processes.

 

Key Responsibilities:

  • Provides technical guidance and regulatory training/mentoring to cross-functional teams.
  • Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
  • Develops and implements regulatory strategies for new and modified 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.
  • Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
  • Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
  • Supports highly technical or major business segment product lines, special projects or strategic initiatives.
  • Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support.
  • Ensures appropriate training is maintained to do the work and training is documented.

 

Qualifications:

  • Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
  • 3+ years Regulatory Affairs experience, medical device experience required
  • Working knowledge of FDA and international regulations
  • General understanding of product development process and design control
  • Working knowledge of regulatory requirements for capital equipment 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: 433103

 


Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto

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