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Principal Clinical Evaluation Scientist Job

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Date: Mar 31, 2021

Location: Arden Hills, MN, US, 55112

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.

 

About this role:

This is a highly dynamic role in which you will work in a team environment to help develop global evidence-based clinical strategies for cardiology medical devices (CRM and Electrophysiology) by creating clinical documentation that systematically synthesizes information from multiple data sources. As a Clinical Evaluation Scientist, you will plan and develop clinical evaluation reports (CERs) and post-market clinical follow-up (PMCF) reports, as well as summary of safety and clinical performance reports (SSCPs) in alignment with applicable clinical and regulatory standards and business needs. This role applies analytical thought processes and a highly methodical clinical evaluation approach to develop benefit/risk profiles for the Boston Scientific portfolio cardiology devices. A successful candidate has excellent writing skills as well as the ability to work collaboratively with cross-functional partners. Your efforts support product approval, indication expansion and claim support, and mandated post-market requirements.

 

Your responsibilities will include:

  • Compile, appraise, and evaluate data from multiple sources including clinical trials, medical literature, design verification/validation data, and product complaint data. Includes development of literature search strategies and methodical evaluation of medical literature.
  • Create analyses to evaluate product benefit/risk profile and safety and performance and develop profile of adverse events. Identify potential clinical evidence gaps and contribute to development of prospective evidence strategy to address gaps.
  • Collaborate with leadership and cross-functional partners to develop global clinical strategies for new product development and/or EU MDR certification, ensure alignment of clinical data with risk documentation, and to contribute to product labeling.
  • Aid in the development and execution of strategies for regulatory responses for regulatory submissions

   

What we’re looking for in you: 

Minimum Qualifications

  • Bachelor’s/Master’s degree and 8+ years professional experience or Advanced degree (PhD, research-based MS, MD, RN/DVM) and 3+ years professional experience
  • Analytical skills, including strong familiarity with medical literature
  • Strong medical/scientific writing skills

Preferred Qualification

  • Knowledge of cardiac rhythm management and electrophysiology medical device products and related disease states/ medical terminology
  • Medical device experience, including understanding of regulatory
  • 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.

 

Requisition ID: 474420

 


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