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Senior Specialist, Electrophysiology, Reg Affairs Job

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Date: Jul 21, 2019

Location: Arden Hills, MN, US, 55112

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, you’ll discover a place where you can have meaningful purpose, improving lives through your life's work. In Electrophysiology, we offer a broad range of technologies, such as mapping catheters, and radiofrequency energy, for diagnosing and treating heart rhythm disorders.

 

 

Position Summary:

Under minimal supervision, the Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified body and other country specific regulatory bodies.  The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews.

 

 

Position Responsibilities:

  • Develops domestic and international strategies for regulatory approval of company products
  • Coordinates, compiles and submits U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country specific product registrations
  • Develops and maintains positive relationships with regulatory body reviewers through oral and written communications regarding clarification and follow-up of submissions under review
  • Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
  • Represents RA on cross functional product development, manufacturing and clinical support teams and provide regulatory feedback and guidance throughout the product development cycle
  • Technical and labeling reviews of supporting documents for inclusion in regulatory filings
  • Represents RA on other cross functional projects which may include process changes and continuous improvement efforts.

 

 

Qualifications:

  • BA/BS degree preferably in life sciences or engineering or an equivalent
  • Minimum 5 years regulatory affairs or related experience.  Previous experience with Class III medical devices submissions is desired
  • Demonstrated proficiency with relevant US/International regulatory requirements for medical devices including Quality Systems standards and clinical investigations
  • Experience working directly with FDA, notified bodies and/or international health authorities is desired
  • Strong technical, research and problem-solving skills
  • Ability to communicate complex ideas clearly and simply both orally and in writing
  • Demonstrated ability to effectively manage multiple projects and priorities
  • Team player with excellent interpersonal skills
  • Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

 

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: 447989

 


Nearest Major Market: Minneapolis

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