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Senior Clinical Product Risk Specialist, Endoscopy Job

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Date: Sep 1, 2021

Location: Marlborough, MA, US, 01752

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.



*** This role does have the opportunity to be remote


About the role:

The Senior Clinical Product Risk Specialist is responsible for the analysis and communication of clinical product risk across the project and product lifecycle.  Provides guidance in safety signal detection and assessment to communicate safety risks to project teams and senior management.  Ensures compliance with regulatory standards and guidelines, and corporate standard operating procedures as they relate to safety risk management.


Your responsibilities will include:

  • Identify appropriate scope and comparative information for Clinical Evaluation Reports (CER) and drive generation or updates for those documents.  Collaborate with cross-functional partners to obtain additional input to aid in clinical risk analysis
  • Conduct literature searches on products/product families to interpret and summarize harms, hazards, alternate therapies and device specific benefits from literature to support risk assessment.
  • Identifies the need for and/or generates risk management related documents on BSC products (commercial or under development) to support internal BSC and external regulatory agency requirements
  • Serves as a liaison between Risk Management function and project team.  Clearly communicates pertinent project/function information.
  • Collaborate with Clinical and R&D to develop common Clinical deliverable criteria and strategize justification for no clinical trial or aid in development of clinical trial rationalization plan.
  • Mentors and serves as subject matter expert in key risk management activities; participates as a risk management consultant for complex projects and for grouping similar products into logical and sustainable structure.
  • Dependent on level, may serve as SME and Function representative in internal and external audits including audit participation, back room SME, preparing audit responses and supporting process improvements resulting from the audit.


What we're looking for in you:

Minimum Qualifications

  • Bachelor’s degree in Life Sciences
  • 5+ years experience in Pre Clinical or Clinical Research environment
  • Medical and/or technical writing experience required regarding medical device products
  • Previous experience working with CERs CE Marks and EU MDRs

Preferred Qualifications

  • Medical Device industry experience preferred
  • Endoscopy therapeutic area knowledge desired
  • Ability to work cross functionally at all levels of organization
  • Proven ability to analyze, interpret and synthesize clinical and commercial data



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: 476266


Nearest Major Market: Boston

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