Boston Scientific · 4 hours ago
Senior Clinical Evaluation Scientist
Arden Hills, MN
Full-time
Hybrid
Mid, Senior Level
$85K/yr - $162K/yr
4+ years expBoston Scientific is a leader in medical science dedicated to solving significant health industry challenges. The Senior Clinical Evaluation Scientist will support the Electrophysiology Solutions portfolio by developing clinical documentation to support product approval and compliance with regulatory standards, collaborating across functions to ensure alignment with clinical and regulatory requirements.
Health CareMedicalMedical Device
No H1B
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
Qualification
Required
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
Preferred
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
Benefits
Annual bonus target
Long-term incentives
Variable compensation from time to time
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
2026-01-22
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