Senior Clinical Evaluation Scientist

Boston Scientific • Arden Hills, MN

6d • Hybrid

About The Position

As a Senior Clinical Evaluation Scientist supporting the Electrophysiology (EP) Solutions portfolio, you'll play a critical role in shaping global evidence-based clinical strategies. Your role will develop key clinical documentation that synthesizes complex data across sources to support product approval, market access, and compliance with post-market requirements. This is a highly collaborative role and will allow you to work 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 in this position.

Requirements

• 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 the following 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 radiofrequency 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.

Nice To Haves

• 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.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees