- Virtual Address, Virtual, MI, 00000, US
- Remote-US
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Job description
We are seeking a Senior Clinical Evaluation Specialist to join our Instruments division. In this role, you will apply scientific, regulatory and project management skills to establish the evaluation strategy and compile a body of clinical evidence, in order to reach a legally binding scientific conclusion on the safety and performance of medical devices throughout the product lifecycle. The CES bears the operational responsibility of individual clinical evaluation reports and associated documents.
What you will do
- Support a coherent clinical evidence strategy throughout the new product development cycle, and foster alignment with adjacent complex processes (marketing strategy and claims, regulatory strategy, clinical research strategy, testing strategy).
- Support compliant and sustainable literature search strategies, and perform complex literature queries to retrieve published clinical data,
- Identify, appraise, and analyze all relevant data (clinical, PMS, marketing, testing, etc.) from multiple sources and formats and create a comprehensive scientific review.
- Analyze the current medical and scientific trends in the clinical state of the art on a broad variety of specialized indications and techniques.
- Identify unanswered questions and residual risks in the clinical evaluation report, and assist with design of Post Market Clinical Follow Up (PMCF) activities in collaboration with clinical affairs colleagues and/or other subject matter experts to address these questions.
- Define and develop clinical evaluation and analysis methodologies to adapt to a complex and quickly evolving regulatory and scientific framework.
What you need
- Bachelor of Science degree in a health‑ or science‑related discipline required.
- Minimum of 2 years industry experience in clinical, quality or regulatory affairs (risk management, design quality, post-market safety, etc.).
- Experience in writing clinical evaluations for medical devices required.
- Demonstrated experience analyzing clinical, post‑market, and preclinical data in accordance with global regulatory requirements (e.g., FDA, EU MDR).
Preferred
- Master’s degree in a health‑ or science‑related field preferred; PhD strongly preferred.
- Experience in scientific or medical writing, relevant academic or clinical research experience (PhD, Post-doc) is preferred.
- Ability to understand and communicate new medical topics, including disease states, treatment rationales, surgical techniques, and clinical outcomes.
Posted Date: 05/18/2026 This role will be posted for a minimum of 3 days.
United States of America Pay Ranges:
- USN: $83,300 - $138,800 USD Annual
- US5: $87,500 - $145,700 USD Annual
- US10: $91,600 - $152,700 USD Annual
- US15: $95,800 - $159,600 USD Annual
- US20: $100,000 - $166,600 USD Annual
- US30: $108,300 - $180,400 USD Annual
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Click here to learn more about: US Stryker employee benefits Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
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