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Interventional Cardiology Senior Clinical Product Risk Specialist Job

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Date: Jul 29, 2019

Location: Maple Grove, MN, US, 55311

Company: Boston Scientific

Additional Locations: US-MA-Marlborough



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.


About this role:

Primarily responsible for drafting Clinical Evaluation Report and related documentation for interventional cardiology and/or structural heart medical devices. Responsible for the analysis and communication of clinical product risk across the project and product lifecycle. Provides guidance in clinical risk assessment and communicates safety risks to project teams, senior management, and regulatory agencies. Ensures compliance with regulatory standards and guidelines, and corporate standard operating procedures as they relate to clinical risk management.  Works with team to assess sufficiency of clinical data and develop post-market clinical follow up plans.


 Your responsibilities will include:

  • Identify appropriate scope and comparative information for clinical experience reports and drive generation or updates for those documents. Collaborate with cross-functional partners to obtain additional input (i.e. Design Quality, Medical, Regulatory) to aid in clinical risk analysis
  • Conduct literature search on products to interpret and summarize clinical data as well as adverse events, hazards and device-specific benefits from literature; collect and summarize primary data from the Design History File to support risk assessment
  • Collaborate cross-functionality to develop common Clinical deliverable criteria and strategize justification for no clinical trial or aid in development of clinical trial rationalization plan. Collaborate with Medical Sciences by providing harms, hazard and benefits information for the development/updates of the DFU, and risk management (including FMEA) documents.
  • Work with project teams on alignment of adverse events across clinical and quality documentation.
  • Develops and executes strategies for regulatory responses for regulatory submissions


What we’re looking for in you: 

Minimum Qualifications

  • Bachelor’s degree in Science/Engineering 
  • 4+ years professional experience
  • Ability to review and synthesize medical publications and/or competitive product literature
  • Medical/scientific writing skills 

Preferred Qualifications

  • Master’s or above
  • Related experience - Cardiology, Vascular, Clinical Risk, Safety, Risk Management, Regulatory Writing
  • Strong analytical skills - ability to synthesize and summarize medical and technical literature.  Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors
  • Ability to understand engineering documentation, including risk documentation


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: 450052


Nearest Major Market: Minneapolis

Job Segment: Cardiac, Clinic, Risk Management, Medical, Engineer, Healthcare, Finance, Engineering