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Sr Clinical Product Risk Specialist 1 Job

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Date: Jun 30, 2019

Location: Diegem, BRU, BE, 0

Company: Boston Scientific

About the role:

Responsible for participating in cross functional development teams as the clinical representative in support of the organization's business objectives for product development and/or commercialization as well as sustaining.  Possesses medical writing expertise, understanding of scientific research methodologies, technical knowledge of products, processes, and regulatory requirements to conduct clinical risk assessment within a given therapeutic area.


Your responsibilities include: 

  • Writes Clinical Evaluation Reports by evaluating scientific literature and publications, reviewing hazard analyses and other risk documents, reviewing product complaint data, analyzing scientific data and staying abreast of current clinical practice. Creates relevant clinical documentation in support of related clinical evaluation deliverables to comply with applicable clinical and regulatory standards. May collaborate on risk assessment and writing of product labeling. 
  • Interacts with various contributory functions to coordinate clinical content in documents supporting regulatory interactions related to clinical trial activities, post-approval requirements and questions from various regulatory bodies. Contributes to regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.  
  • Collaborates cross-functionally with Sales and Marketing, R&D, Regulatory Affairs, Quality, and Medical Director/Medical Safety to drive toward project deliverables. 
  • Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies.  May include clinical risk management activities including input into Hazard Analyses, product FMEA and DFUs for identification of harms and support of safety performance for product approval.


    What we're looking for:

    Basic Qualifications

  • Bachelor’s degree with a scientific focus and 3+ years of related work experience or an equivalent combination of education and work experience.
  • Medical/Technical writing experience.
  • Ability to review and synthesize medical publications and/or competitive product literature
  • Excellent communication skills (written and verbal).


    Preferred Qualifications

  • Electrophysiology (EP) and/or Cardiac Rhythm Management (CRM) Clinical Risk/Safety/Trial experience preferred, technical experience is desirable.
  • Medical experience highly desirable.
  • Ability to apply comprehensive technical knowledge to resolve complex issues in creative ways.
  • Ability to use in-depth knowledge of business unit functions and cross group dependencies/relationships.
  • Strongly prefer a professional with a wide-range of experience and expertise in a specialized technical field.



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