[Remote] Senior Staff Clinical Evaluation Specialist (Remote)

Note: The job is a remote job and is open to candidates in USA. Stryker is hiring a Senior Staff Clinical Evaluation Specialist for its Surgical Technologies business unit. The role leads clinical evidence strategies and scientific documentation supporting regulatory submissions, market access, and product lifecycle decisions, while partnering with cross-functional teams to evaluate and communicate evidence.

Responsibilities

• Lead the development and execution of clinical evidence strategies for new product development and lifecycle management activities
• Manage clinical evaluation projects, ensuring alignment between 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 into scientifically supported conclusions
• Assess benefit-risk profiles of medical devices 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 identify opportunities to improve clinical evaluation methodologies, documentation practices, and team efficiency

Skills

• 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
• Doctoral degree (PhD, PharmD, MD, or equivalent) in a health or science-related discipline
• Experience supporting global medical device regulatory requirements, including clinical evaluation, post-market surveillance, and market access activities
• Experience developing scientific publications, conference presentations, and clinical evidence communication strategies
• Experience managing complex cross-functional projects within the medical device industry

Benefits

• Remote position within the United States; candidates must reside in the Eastern or Central time zones.

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