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Specialist II, Interventional Cardiology, Reg Affairs Job

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Date: Mar 26, 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 an experienced Regulatory Affairs Specialist II to work in our rapidly growing Coronary Therapies franchise.  This role will provide a regulatory professional the opportunity to develop and execute regulatory strategies across the full lifecycle of interventional cardiology technologies from inception, through clinical trials and through commercialization.

 

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.

 

 Your responsibilities include:

  • Implements regulatory strategies for new and modified medical devices.
  • Acts as a core member on manufacturing and development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
  • Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation.
  • Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
  • Act as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submissions strategy/regulatory pathway development testing requirements, clarification and follow-up of submissions under review.

 

What we’re looking for:

Minimum Qualifications

  • BA/BS Degree in life sciences or engineering or an equivalent (Advanced Degree is a plus)
  • 2+ years regulatory affairs experience (within the high-risk medical device field preferred)
  • Specific experience in strategic planning, preparation, and submission of 510(k)s, Technical Files, and Design Dossiers is required.
  • Demonstrated proficiency with relevant US/International regulatory requirements for medical devices (particularly for US Class II/EU Class III devices; experience with US Class III is a plus)
  • Experience working directly with FDA, Notified Bodies and/or international health authorities is desired
  • 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
  • Travel up to 10%

 

 

Requisition ID: 476964

 

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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