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Specialist I, Interventional Cardiology, Reg Affairs Job

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Date: Apr 29, 2021

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

Additional Locations:

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

 

Boston Scientific (BSC) is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world. We are looking for a Regulatory Affairs Specialist I to work in our rapidly growing Coronary Therapies franchise. 

 

We are looking for future regulatory leaders to partner with our global R&D and quality teams in our continued journey to evolve technologies and drive future generations of products.

 

We seek a dynamic individual focused on professional development in an innovative environment offering a diverse mix of regulatory opportunities encompassing the full life cycle of both lower risk (Class ll) and high risk (Class lll) cardiovascular devices. If this strategic and critical role excites you, we would love to talk.

 

Key Responsibilities:

  • Supports the coordination, drafting, and submitting of U.S., EU MDR and international regulatory filings for new and modified products  
  • Provides technical reviews of test protocols and reports for inclusion in regulatory filings
  • Assessment of labeling materials for regulatory filings
  • Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
  • Represents RA on cross functional product development 
  • Participates in corporate and departmental training 
  • Assists International BSC Regulatory colleagues with international regulatory filings
  • Works as liaison with International BSC Regulatory on various projects

 

What we’re looking for in you:

  • BA/BS Degree in life sciences, engineering or an equivalent
  • 2+ years of medical device experience 
  • 1+ year of EU MDR Experience 
  • Ability to communicate complex ideas clearly and simply both orally and in writing
  • Demonstrated ability to effectively manage multiple projects and priorities in a timeline driven environment
  • 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

 

 

Requisition ID: 479979

 

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

 

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

 

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.


Nearest Major Market: Minneapolis

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