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Regulatory Affairs Specialist II

2 months ago

Maple Grove, United States Boston Scientific Full time

Recruiter: Spencer Gregory Hale

 

Regulatory Affairs Specialist II

 

About the role:

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.

 

The Specialist II is responsible for Regulatory Affairs support of global regulatory submissions for the BSC product development process, integration of acquired products, and ongoing regulatory compliance.

 

Your responsibilities will include:

  • Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
  • Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification, and follow-up of submissions under review.
  • Develops and implements regulatory strategies for new and modified products.
  • Acts as a core member on sustaining manufacturing and/or product development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
  • Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
  • Reviews device labeling for compliance with global regulations; analyzes and recommends appropriate changes.
  • Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
  • Develops and implements departmental and divisional policies and procedures.
  • Supports highly technical or major business segment product lines, special projects or strategic initiatives.
  • Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.

 

Required qualifications:

  • Minimum of a bachelor’s degree, preferably in a scientific or technical discipline. Professional certification(s) preferred
  • Minimum of 2 years of related experience in the medical device industry including some regulatory affairs experience

 

Preferred qualifications:

  • 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

 

 Requisition ID: 587428

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.