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Principal Specialist, Urology, Reg Affairs Job

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Date: Aug 1, 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.

 

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. These conditions account for 50 percent of all urology surgical procedures.  Additionally, we continue to invest in gynecologic surgical solutions for the treatment of abnormal uterine bleeding and uterine fibroids.

 

Job Purpose:

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

 

Key Responsibilities:

  • Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional 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 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 device labeling and advertising materials for compliance with global 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.
  • Develops and implements departmental and divisional policies and procedures.
  • Supports highly technical or major business segment product lines, special projects or strategic initiatives.  
  • An understanding of standards, in particular the IEC 60601 series of standards as well as IEC 62304 and capital equipment, radio frequency, interoperability and usability are a plus.

 

Qualifications:

  • Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
  • Professional certification(s) preferred
  • 8+ years Regulatory Affairs Medical Device experience
  • Thorough understanding of global regulations
  • Strong technical knowledge of medical products
  • Strong technical understanding of relevant procedures, practices, and associated medical terminology
  • Thorough knowledge of product development process and design control
  • Excellent research and analytical skills
  • Program Management experience
  • Excellent written and oral communication, technical writing and editing skills
  • Strong leadership, interpersonal and influencing skills
  • Proficiency with Microsoft Office, Excel, PowerPoint

 

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: 450244

 


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