Senior Clinical Evaluation Lead — Remote

Stryker; United States; Remote; USD 110,000 - 238,000; Full time

Job summary

Stryker is seeking a Senior Staff Clinical Evaluation Specialist for the Surgical Technologies business unit. This is a remote position within the United States, with a preference for candidates in the Eastern or Central time zones.

You will lead development of clinical evidence strategies, author evaluations, and support regulatory submissions across the product lifecycle. Collaboration with Regulatory Affairs, Clinical Research, Marketing, Reimbursement & Market Access, Quality, and Product

Qualifications

• Master of Science in health/clinical/biological science or related field.
• Minimum 6 years in clinical affairs, regulatory affairs, quality, medical writing, clinical evaluation, or related medical device roles.
• Minimum 2 years authoring clinical evaluations for medical devices.
• Experience conducting literature reviews, evidence synthesis, and analysis using clinical/technical data.
• Experience supporting regulatory submissions and lifecycle activities in regulated healthcare.
• Fluency in English.

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

Clinical affairs

Regulatory affairs

Quality

Medical writing

Clinical evaluation

Post-market surveillance

English fluency

Education

Master of Science in health/science or related field

Doctoral degree (PhD/MD/PharmD) preferred

Job description

Stryker is seeking a Senior Staff Clinical Evaluation Specialist for the Surgical Technologies business unit. This is a remote position within the United States, with a preference for candidates in the Eastern or Central time zones.

You will lead development of clinical evidence strategies, author evaluations, and support regulatory submissions across the product lifecycle. Collaboration with Regulatory Affairs, Clinical Research, Marketing, Reimbursement & Market Access, Quality, and Product