Senior Clinical Evaluation Scientist

Overview

Additional Location(s): N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit
- High Performance

At Boston Scientific, we aim to empower you to grow by working in diverse, high-performing teams tackling key health industry challenges. You’ll have access to the latest tools, information and training to advance your skills and career, with support for your progression and ambitions.

As a Senior Clinical Evaluation Scientist supporting the Electrophysiology (EP) Solutions portfolio, you will shape global evidence-based clinical strategies. You will develop clinical documentation that synthesizes data across sources to support product approval, market access, and post-market compliance. This highly collaborative role involves working across functions to develop Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up (PMCF) reports, and Summary of Safety and Clinical Performance (SSCP) reports, ensuring alignment with global clinical and regulatory standards.

Strong analytical and writing skills, combined with scientific and regulatory insight, are essential for success.

This role follows a hybrid work model requiring presence in a local office (Minnesota or Marlborough) at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

• Compile, appraise, and evaluate data from diverse sources including clinical trials, medical literature, design verification/validation data, and product complaint data.
• Align data with risk documentation and product labeling to identify clinical gaps or emerging concerns.
• Collaborate with librarians to design literature search strategies and perform systematic reviews including screening, appraisal, and data extraction.
• Partner with medical experts to define clinical benefit statements and align pre- and post-market evidence strategies accordingly.
• Conduct analyses to evaluate product benefit/risk profiles, safety signals (e.g., adverse event trends), and performance indicators.
• Identify evidence gaps and contribute to strategies for generating new data.
• Develop global clinical data strategies in collaboration with leadership to support market access for new product development, sustaining products, and design changes.
• Support Design and Quality activities, including impact assessments and new clinical data planning, ensuring cross-functional alignment and resourcing.
• Contribute to development and execution of regulatory submission strategies.

• Minimum Bachelor’s, Master’s, or advanced degree (PhD, research-based MS, MD, RN, DVM) in a scientific, medical, or engineering field.
• Minimum of 4 years' experience in a scientific, engineering, medical, or medical device environment.
• Minimum of 3 years' experience in at least one of these areas:
• Developing Clinical Evaluation and Post-Market Clinical Follow-Up Plans/Reports in compliance with EU MDR 2017/745, MDCG guidance, and harmonized standards
• Clinical treatment and management of patients undergoing EP therapies, including radio frequency ablation, cryoablation, or pulsed field ablation
• Preparing, managing, and submitting Regulatory Technical Documentation in accordance with EU MDR 2017/745
• Strong understanding of different types of clinical evidence (e.g., literature, clinical trials, real-world evidence) and their strengths and limitations.
• Proven ability to strategically apply regulatory and medical knowledge to clinical data planning.
• Proficient in literature analysis and appraisal.
• Demonstrated medical and scientific writing skills.

• Minimum of 3 years' experience in more than one of the areas listed above.
• Familiarity with Quality Management System documentation, including Risk Management Documents (e.g., Hazard Analysis, Risk Management Report, Risk Management Plan).
• Experience working with engineering documentation such as test protocols, test reports, and relevant international standards.

Requisition : 622739

Minimum Salary: $85,000

Maximum Salary: $161,500

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