Boston Scientific Senior Clinical Evaluation Scientist 

United States, Massachusetts, Marlborough 

788082582

About this role:

As a Senior Clinical Evaluation Scientist, you will 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.

Your responsibilities will include:

• Apply analytical and methodical clinical evaluation approaches to develop benefit-risk profiles for Boston Scientific’s interventional cardiology devices.
• Author and maintain clinical documentation including CERs, PMCF reports, and SSCPs in alignment with regulatory standards.
• Collaborate cross-functionally to ensure clinical content supports product approvals, indication expansions, claims, and post-market requirements.
• Interpret and synthesize data from multiple sources to produce high-quality, compliant clinical evaluations.
• 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 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

Required qualifications:

• Minimum bachelor’s degree and 4 years of medical writing experience
• Analytical skills, including strong familiarity with medical literature
• Proven experience writing clinical evaluation reports
• Proven experience applying principles of EU MDR

Preferred qualifications:

• Preferred medical device industry experience or knowledge of interventional cardiology and related disease states
• Proven and demonstrated ability to understand engineering documentation, including risk documentation
• Proven experience with regulatory body communications

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.