Job Overview
Location
Michigan, Portage 1941 Stryker Way
Job Type
Full-time
Category
Other
Date Posted
April 22, 2026
Full Job Description
đź“‹ Description
- • Lead the development, authoring, and revision of high‑quality clinical and regulatory documentation, including regulatory submissions and pre‑subs, clinical evaluations, post‑market surveillance and PMCF reports, SSCPs, annual reports, and clinical studies supporting device safety and performance.
- • Design and execute compliant systematic literature reviews to capture, assess, and summarize published clinical evidence.
- • Identify, critically appraise, and analyze clinical, post‑market, preclinical, and marketing data to develop comprehensive scientific and clinical evidence packages, including quantitative and qualitative analyses and risk‑management cross‑checks.
- • Serve as a clinical evidence subject matter expert, partnering cross‑functionally with Regulatory Affairs, Clinical Research, Marketing, and Reimbursement & Market Access to support evidence communication and business alignment.
- • Communicate and negotiate with global regulatory bodies on clinical evidence requirements, leading issue resolution to ensure successful regulatory submission acceptance.
- • Support new product development by providing clinical input to design teams, intended use and indications for use statements, risk files, and product claims.
- • Support product sustainment initiatives to maintain market availability and enable new or expanded claims based on evolving clinical evidence.
- • Review marketing collateral to ensure accuracy, consistency, and compliance of clinical claims.
- • Foster open scientific dialogue and appropriately challenge conclusions to ensure evidence‑based decision‑making in the best interest of patients and customers.
🎯 Requirements
- • Bachelor of Science degree in a health‑ or science‑related discipline required.
- • Minimum of 4+ years of industry experience in clinical, quality, or regulatory affairs (e.g., risk management, design quality, post‑market safety).
- • At least 3 years of direct experience authoring clinical evaluations for medical devices, including preparation of submission‑ready clinical evidence documentation.
- • Demonstrated experience analyzing clinical, post‑market, and preclinical data in accordance with global regulatory requirements (e.g., FDA, EU MDR).
- • Master’s degree in a health‑ or science‑related field preferred; PhD strongly preferred.
- • Strong ability to interpret and apply regulations, technical standards, guidance documents, and complex clinical and technical data to support regulatory and market access strategies.
🏖️ Benefits
- • Remote work flexibility – based anywhere in the United States.
- • Competitive pay ranges based on location and experience, from $95,700 to $191,400 annually.
- • Opportunity to collaborate with cross‑functional teams including Regulatory, Clinical Research, Quality, and Marketing.
- • Travel percentage of 20% for engagement with global regulatory bodies and stakeholders.
- • Equal opportunity employer committed to diversity, inclusion, and fair compensation practices.
- • Support for professional growth through involvement in new product development and product sustainment initiatives.
Skills & Technologies
About Stryker Corporation
Stryker Corporation is a Fortune 500 medical technology company headquartered in Kalamazoo, Michigan. It designs, manufactures and sells orthopedic implants, surgical instruments, endoscopy systems, neurovascular devices, emergency medical equipment and patient handling equipment to hospitals and healthcare providers worldwide. Founded in 1941 by orthopedic surgeon Homer Stryker, the company operates in over 75 countries with more than 50,000 employees. Its products serve multiple medical specialties including orthopedics, spine, neurotechnology, and med-surg. Stryker focuses on innovation, investing over $1 billion annually in R&D to improve patient outcomes and healthcare efficiency through advanced medical technologies and minimally invasive surgical solutions.
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