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Senior Specialist, Interventional Cardiology, Reg Affairs Job

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Date: Nov 15, 2018

Location: Maple Grove, MN, US, 55311

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:

In Interventional Cardiology (IC) we design, develop, and produce technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders.

 

Responsible for Regulatory Affairs support of the product development process, submissions and regulatory compliance within our Structural Heart Business.

 

 Your responsibilities include:

  • 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.
  • Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation.
  • Collaborates with regional business partners in support of international product registrations.
  • Assists with departmental policy and procedure implementation.
  • Acts as a core team member on manufacturing development teams, providing regulatory affairs feedback and guidance throughout the product development cycle.
  • Reviews device labeling and promotional materials for compliance with global submissions and applicable regulations; analyzes appropriate changes
  • Reviews and signs-off on product/manufacturing changes for compliance with applicable regulations and guidances.
  • Build quality into all aspects of their work by maintaining compliance to all quality requirements.

 

 What we’re looking for:

  • Bachelor’s degree in a scientific or technical discipline required; advanced degree preferred
  • 5+ years Regulatory Affairs high-risk medical device industry experience required; specific structural heart medical device experience preferred
  • Proficient in preparing various types of regulatory submissions including PMA, IDE, 510(k), EU Technical files and Design Dossiers.
  • RAC certification preferred, not required
  • Working knowledge of FDA, EU and international regulations
  • General understanding of product development process and design control
  • Ability to manage several projects within assigned timelines
  • Proficiency with Microsoft Word, Excel and PowerPoint required. Proficiency with Microsoft Access and Project desirable
  • 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: 439247

 


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