Senior Staff Clinical Evaluation Specialist

Job not on LinkedIn

🔥 22 minutes ago

🚗 Michigan – Remote

🚗 Michigan – Remote

💵 $110.1k - $238.4k / year

⏰ Full Time

🟠 Senior

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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 the development and execution of clinical evidence strategies for new product development and lifecycle management activities • Manage clinical evaluation projects, aligning clinical evidence, regulatory strategy, product claims, and commercialization objectives • Author and maintain clinical evaluations, post-market clinical follow-up reports, safety and performance summaries, regulatory submissions, annual reports, and other clinical documentation • Design and execute systematic literature reviews, evaluate published evidence, and synthesize clinical, preclinical, and post-market data • Assess medical-device benefit-risk profiles and develop evidence-based recommendations in accordance with global regulatory requirements • Partner with regulatory authorities and internal stakeholders to address clinical evidence requirements and support regulatory submissions • Develop scientific communications, including manuscripts, conference abstracts, presentations, white papers, and customer-facing evidence materials • Mentor team members, lead cross-functional review processes, and improve clinical evaluation methodologies, documentation practices, and team efficiency • Collaborate with Regulatory Affairs, Clinical Research, Marketing, Reimbursement & Market Access, Quality, and Product Development teams • Travel percentage: 10%

🎯 Requirements

• Master of Science degree in a health, clinical, biological science, biomedical, engineering, or related scientific field • Minimum 6 years of experience in clinical affairs, regulatory affairs, quality, medical writing, clinical evaluation, post-market surveillance, or related medical device functions • Minimum 2 years of experience authoring clinical evaluations for medical devices • Experience conducting literature reviews, evidence synthesis, and scientific analysis using clinical and technical data • Experience supporting regulatory submissions and product lifecycle activities within a regulated healthcare industry • Fluency in English • Preferred: Doctoral degree (PhD, PharmD, MD, or equivalent) in a health or science-related discipline • Preferred: Experience supporting global medical device regulatory requirements, including clinical evaluation, post-market surveillance, and market access activities • Preferred: Experience developing scientific publications, conference presentations, and clinical evidence communication strategies • Preferred: Experience managing complex cross-functional projects within the medical device industry • Must reside in the Eastern or Central time zones

🏖️ Benefits

• Remote or hybrid or onsite work flexibility • Remote position within the United States for candidates residing in Eastern or Central time zones • Equal opportunity employment • Pay transparency protections • 10% travel allowance/coverage