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Senior Specialist, Structural Heart, Reg Affairs Job

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Date: Jun 4, 2019

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.

 

Are you interested in working on cutting edge technologies in the fast-paced cardiovascular medical device space? 

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 Senior Regulatory Affairs Specialist to work in our rapidly growing Structural Heart franchise.  This role will provide a regulatory professional the opportunity to develop and execute regulatory strategies across the full lifecycle of cutting edge interventional cardiology technologies from inception, through clinical trials and into commercialization. With the emergence of minimally invasive Transcatheter approaches to Aortic Valve Replacements (TAVR) and Mitral Valve Repair the opportunity to impact the lives of countless patients globally is enormous at Boston Scientific.

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.  The bullets below summarize some of BSC’s exciting investments in the rapidly growing Structural Heart space over the past several years. 

BSC has two distinct TAVR valve platforms that we intend to bring to the US market, the Lotus Edge and the Acurate TAVR systems. Offering two distinctly designed TAVR devices will allow physicians to better tailor tratement to specific patients to drive positive patient outcomes.

http://www.bostonscientific.com/en-US/medical-specialties/structural-heart/structural-heart-disease-therapies/TAVR-portfolio.html

 

  • The Recent acquisition of Claret Medical, manufacturer of the Sentinel Cerebral Protection System is yet another example of BSC’s commitment to patient care.  This important ancillary technology protects or patients from the risk of stroke during endovascular procedures such as TAVR. 

https://www.claretmedical.com/us-healthcare-professionals/technology/protected-tavr-with-sentinel-cps/

 

  • BSC’s LAAC closure device, Watchman, is the Only FDA‑Approved Device Proven to Safely and Effectively Reduce Stroke Risk in Patients with Non-valvular atrial fibrillation (NVAF).  By closing off the LAA, the risk of stroke may be reduced, and over time patients may be able to stop taking anticoagulants.

https://www.watchman.com/en-us-hcp/laac-nvaf-patients/watchman-laac-device-procedure.html

 

  • Announced early January 2019 Boston Scientific’s latest deal (expected to formally close Q1 2019) involves an acquisition of the privately held company, Milipede Medical.  Milipede is in early stages of developing the IRIS transcatheter annuloplasty ring, a system designed to treat patients with severe mitral regurgitation. Mitral and tricuspid regurgitation, are conditions which lead to poor quality of life, cardiac decompensation and early death, and affect over 4 million people in the US alone. Millipede’s IRIS annuloplasty ring system has been developed to meet the growing challenges of treating these patients.  Bank of America and Merrill Lynch analysts believe this space could be “the most important MedTech growth market of the next decade”. 

http://millipedemedical.com/iris.html 

 

We're looking for 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 (510k/tech file) and high risk (IDE/PMA/Design Dossier) cardiovascular devices.  If this strategic and critical role excites you, we would love to meet you.

 

What we’re looking for in you:

  • BA/BS Degree in life sciences or engineering or an equivalent (Advanced Degree is a plus).
  • 5+ 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.  Experience in submitting Q submissions, Pre-IDEs, and IDEs is preferred.  Experience in Class III U.S. submissions is a plus.
  • Global mindset
  • 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
  • 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
  • Ability to travel at least 15%

 

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: 447249

 


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