Staff Clinical Evaluation Specialist

🔥 20 hours ago

🏖️ New Jersey, North Carolina, +2 more states – Remote

🏖️ New Jersey – Remote 🌲 North Carolina – Remote ❄️ Minnesota – Remote 🔔 Pennsylvania – Remote

💵 $95.7k - $207.4k / year

⏰ Full Time

🔴 Lead

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Stryker

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1941

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Stryker is a global leader in medical technology, providing innovative products and services across the healthcare sector. With a presence in countries across the Americas, Asia Pacific, Europe, and the Middle East & Africa, Stryker offers a wide range of medical technologies, including orthopedic implants, surgical equipment, and advanced hospital devices. The company is committed to improving patient outcomes and healthcare efficiency. Stryker continues to expand its global reach, offering localized solutions to meet diverse healthcare needs worldwide.

📋 Description

• Lead preparation and periodic updates of Clinical Evaluation Reports, Clinical Evaluation Plans, Summary of Safety and Clinical Performance documents, Post-Market Clinical Follow-up Plans, and Post-Market Clinical Follow-up Reports • Design compliant, sustainable literature search strategies and conduct systematic literature reviews • Identify, evaluate, and summarize published clinical evidence and current scientific and medical practice • Analyze clinical, post-market surveillance, preclinical, and marketing data using quantitative and qualitative methods • Evaluate device safety, performance, and benefit-risk • Lead clinical evaluation projects and establish clinical evidence strategies throughout new product development • Align clinical evidence with regulatory, clinical research, preclinical testing, marketing, and product claims strategies • Evaluate clinical evidence against U.S., European, and Australian regulatory requirements • Collaborate with medical experts and cross-functional stakeholders to develop scientific conclusions • Identify evidence gaps and residual risks and develop post-market clinical follow-up activities with Clinical Research • Translate clinical data and scientific findings into peer-reviewed publications, white papers, clinical summaries, posters, presentations, and other materials

🎯 Requirements

• Bachelor’s degree required; preferred in Life Sciences, Engineering, or a related field • Minimum 4 years of experience in Regulatory Affairs, Clinical Affairs, Clinical Evaluation, or a related function supporting regulatory or clinical evidence activities • Prior experience within the medical device industry • Experience developing clinical evaluation documentation for medical devices, including Clinical Evaluation Reports, Clinical Evaluation Plans, Summaries of Safety and Clinical Performance, or post-market clinical follow-up documentation • Experience with scientific writing, systematic literature reviews, analysis of published scientific literature, and interpretation of clinical or scientific data • Experience applying U.S., European, or Australian medical device regulatory requirements to clinical evidence or clinical evaluation activities

🏖️ Benefits

• Remote work flexibility • Equal opportunity employment • Pay transparency and compensation discussion protections

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