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Senior Specialist, Peripheral Interventions, Reg Affairs Job

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Date: Aug 7, 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.

 

At Boston Scientific, our products and technologies are used to treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. In Peripheral Interventions (PI) we design, develop, and produce technologies for diagnosing and treating peripheral artery and venous disease. We are able to provide a number of solutions to patients that include: Drug-Eluting Stents, Bare-Metal Stents, Catheters, Balloons, Guide Wires, Atherectomy, Thrombectomy and Intravascular Ultrasound. We have a robust product line and pipeline, and we will continue to make an investment in Peripheral Interventional treatments. 

 

Purpose Statement:

The PI Senior Regulatory Affairs Specialist is responsible for support of the product development process, submissions, regulatory strategies and compliance. 

 

Key Responsibilities:

  • Acts as a core team member on integration, sustaining and new product development teams, providing regulatory feedback and guidance throughout the product development cycle or integration into the BSC Quality System.
  • Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation.
  • Develops regulatory strategies for new and modified US Class 3 and Class 2 medical devices including single-use devices and medical electrical equipment.
  • Reviews and approves product and manufacturing changes for compliance with applicable regulations for both single-use devices and medical electrical equipment.
  • Develops and maintains positive relationships with device reviewers through oral and written communications regarding clarification and follow-up of submissions under review.
  • Assists with Regulatory Affairs training to cross functional groups.

 

Qualifications:

  • Bachelor’s degree, preferably in a scientific or technical discipline. Professional certification(s) preferred
  • 5+ years related experience, medical industry experience preferred; some regulatory affairs experience required
  • Thorough understanding of FDA, European and international regulations
  • Strong working knowledge of medical devices, procedures and terminology
  • Working knowledge of product development process and design control
  • Submission and presentation related computer skills, including experience with software applications such as Microsoft Word, Excel, PowerPoint and Adobe Acrobat
  • Ability to effectively manage multiple projects
  • Excellent written and oral communication, technical writing and editing skills.  Ability to translate technical information into a clearly written message for device reviewers
  • Quick learner, self-motivated, independent worker
  • Strong technical, research and problem solving skills
  • Team player with excellent interpersonal skills

 

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: 449518

 


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