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Director, Peripheral Interventions, Reg Affairs Job

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Date: Feb 15, 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.

 

As the global market leader in peripheral interventions, we offer the broadest portfolio of solutions for treating peripheral artery disease (PAD) and deep vein thrombosis (DVT). We are also focused on our Interventional Oncology portfolio, enabling physicians to minimally invasively treat tumors by delivering targeted and localized embolic and ablative technologies. We’re dedicated to developing technologies that improve outcomes, cut costs and—most importantly—help physicians to save the lives and limbs of more people in more places around the world.

 

Purpose:

Responsible for Regulatory Arterial Franchise activities. Primary responsibilities include the identification, development, and implementation of strategic initiatives, franchise structure, and management development.

 

Key Responsibilities: 

  • Regulatory Lead for the Arterial Franchise
  • Directs and Manages the Arterial Regulatory Team
  • Directs and coordinates the Regulatory Affairs department and related global submission activities
  • Establishes departmental priorities to meet business objectives
  • Ensures that effective regulatory strategies are developed and implemented for new and modified devices to assure timely approval/market clearance/registrations, in support of corporate goals and objectives
  • Ensures compliance with all relevant regulations and guidelines
  • Manages relationships with local regulatory agencies and notified bodies
  • Member of RA Council. Aligns with Regulatory Directors across divisions to encourage consistent practices and implement regulatory priorities
  • Partners with Clinical Research to develop the most effective clinical trial strategies and protocols
  • Represents regulatory on the Arterial Clinical Evidence Planning Team to identify clinical evidence projects that match Arterial priorities
  • Advises divisional management team of prevailing and evolving global regulatory requirements and environment
  • Fosters employee career development
  • Participates in trade and professional organizations including AdvaMed Working groups,RAPID Initiative, and VQI Registry projects
  • Provides regulatory support in new business development activities
  • Fosters relationships with business partners to ensure regulatory compliance
  • Establishes and supports a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support
  • Ensurse employees are trained to do their work and their training is documented

 

Qualifications: 

  • 10+ years of Regulatory Affairs experience and 5+ years of managing people
  • Bachelor’s degree preferably in a scientific, technical discipline or project management, Professional certification(s) preferred
  • Working knowledge of combination devices regulations.   Drug Eluting stent or Drug Coated Balloon technology experience preferred
  • Expertise in PMA, IDE, 510(k), Design Dossier, Technical Files and International Regulatory support

 

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: 442309

 


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