Senior Clinical Evaluation Specialist (Remote)

Stryker • Portage, MI

1d • Remote

About The Position

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.

Requirements

• 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).

Nice To Haves

• 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.

Responsibilities

• 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.

Benefits

• 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.
• Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior