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Principal Regulatory Affairs Specialist Job

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Date: Sep 22, 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.

 

 

Are you interested in working on cutting edge technologies in the fast-paced cardiovascular medical device space?  At Boston Scientific, you’ll have 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.

 

 

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation and improving patient’s lives that keeps us connected on the most essential level. This is a place where you can find a career with meaningful purpose - where we value diversity, respect and initiatives that promote awareness and celebration of personal, cultural, and demographic differences of our customers, patients, and workforce.

 
About the role:
Fueled by innovation, Boston Scientific (BSC) is dedicated to transforming lives through medical solutions that improve the health of patients around the world. We are looking for a Principal Regulatory Affairs Specialist to work in our rapidly growing Structural Heart Franchise.  In this role, you will provide regulatory leadership and strategic direction by partnering with our global Mitral Therapies R&D, Quality and Marketing teams as we progress from early stage clinical evidence generation, through pivotal trials and ultimately global commercialization of our Millipede Transcatheter Annuloplasty Ring System. 

 

This will be an exciting journey!  We seek a dynamic individual looking for a unique opportunity to lead regulatory strategy and execution though the full life cycle of development. If this strategic and critical role excites you, we would love to talk about having you join our team.


Key Responsibilities

  • Develops and implements global regulatory strategies for an innovative transcatheter mitral repair device and other devices within the structural heart space.
  • Acts as a core member on new product development teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for submissions.
  • Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.Identifies, understands, and communicates new or evolving regulatory requirements pertinent to Interventional Cardiology, Mitral Therapies, and Structural Heart technologies.
  • Works cooperatively with R&D, process development, quality, manufacturing, biocompatibility, clinical, and marketing on complex projects to ensure success.
  • Acts as company representative, developing and maintaining positive relationships with global regulatory agencies through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification, and follow-up of submissions under review.
  • Tracks key competitive technologies and provides regulatory assessment in collaboration with new business development and marketing in order to gain alignment with franchise stakeholders.
  • Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.

 

 

What We’re Looking For:

 

Required Qualifications: 

  • A minimum of Bachelor’s degree in a scientific or technical discipline (preferably a BS or MS in Engineering or Biological Sciences).
  • A minimum 8 years Medical Device Regulatory Affairs or related discipline experience within the medical device industry (e.g., R&D, Quality, Clinical, Medical Affairs, Biocompatibility) OR  A minimum of 5 years Medical Device Regulatory Affairs experience with an advanced degree (Master’s, PhD)
  • Thorough understanding of US and EU medical device regulations.
  • Thorough understanding of product development process and design controls.
  • Solid technical knowledge of medical devices, procedures, practices, and related terminology.
  • Excellent organizational, communication and collaboration skill and ability to draw conclusions and make recommendations based on technical inputs from multiple and varied sources 


Desired Qualifications

  • Submission experience with High Risk Medical Devices (Focus on FDA and EU, international experience a plus).
  • Experience in interventional cardiology, specifically structural heart highly desirable.
  • Comprehensive understanding of medical device standards and guidance.
  • Proficient understanding of regulations applicable to conduct of clinical trials.
  • Excellent research and analytical skills.
  • Strong leadership, interpersonal, communication and influencing skills.
  • Demonstrated ability to manage multiple regulatory projects, as well as serve as regulatory lead on projects.
  • Ability to work independently with minimal supervision, as well as mentor/guide others
  • Proficiency with Microsoft Office applications (Word, Excel, PowerPoint).
     

 

 

Requisition ID: 490658

 

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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