Staff Clinical Evaluation Specialist (Remote)

Work Flexibility: Remote

Join Stryker’s Joint Replacement Clinical Affairs team as a Staff Clinical Evaluation Specialist, leading the development and maintenance of clinical evaluation documentation to support brining medical device to market and throughout the product lifecycle. This role combines scientific writing, clinical evidence assessment, regulatory strategy, and project management to support regulatory submissions across multiple global markets.

What you will do

Lead the preparation and periodic updates of Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Summary of Safety and Clinical Performance documents (SSCPs), Post-Market Clinical Follow-up Plans (PMCFPs), and Post-Market Clinical Follow-up Reports (PMCFRs) to support regulatory submissions and ongoing compliance.

Design compliant, sustainable literature search strategies and conduct systematic literature reviews to 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 to evaluate device safety, performance, and benefit-risk.

Lead clinical evaluation projects and establish clinical evidence strategies throughout new product development, aligning clinical evidence with regulatory, clinical research, preclinical testing, marketing, and product claims strategies.

Evaluate clinical evidence against current U.S., European, and Australian regulatory requirements and collaborate with medical experts and cross-functional stakeholders to develop scientific conclusions on device safety and performance.

Identify evidence gaps and residual risks and develop post-market clinical follow-up activities with Clinical Research to address unanswered clinical questions.

Translate clinical data and scientific findings into peer-reviewed publications, white papers, clinical summaries, posters, presentations, and other materials supporting cross-functional business needs.

Required

Bachelor’s degree required. Preferred to be 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.

Preferred

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

United States of America Pay Ranges: USN: $95,700 - $159,500 USD Annual

US30: $124,400 - $207,400 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 0%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.