Work Flexibility: Remote
We are seeking a Staff Clinical Evaluation Specialist to join our Instruments division. In this role, you will collaborate closely with cross-functional teams, including Regulatory, Clinical Research, Quality, and Marketing to ensure the successful preparation of high-quality, submission-ready clinical documents to enable global market availability. These include clinical evaluation reports, post-market clinical follow-up documents, summaries of safety and clinical performance, and clinical study documentation. Candidates may be based Remote, anywhere in the United States.
What you will do
- 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.
- Strong scientific writing skills with the ability to synthesize complex clinical data into clear, compliant, and well‑structured regulatory documents.
- 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.
- Synthesize complex scientific and technical information into clear, concise, and scientifically accurate clinical documents, maintaining documentation throughout the full product lifecycle.
- 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.
- Translate clinical and scientific data into accessible formats for diverse audiences, including regulators, healthcare professionals, and customers; support development of manuscripts, conference posters and presentations, white papers, and customer‑facing materials.
- Communicate and negotiate with global regulatory bodies on clinical evidence requirements, leading issue resolution to ensure successful regulatory submission acceptance.
- Independently resolve content questions and feedback from internal and external reviewers; coordinate cross‑functional review cycles and ensure timely document approvals.
- 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.
What you need
- 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).
Preferred
- 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.
- Demonstrated ability to understand and clearly communicate new medical topics, including disease states, treatment rationales, surgical techniques, and clinical outcomes.
- Proven success managing complex, cross‑functional projects in a regulated environment.
- Strong communication, project management, influencing, and negotiation skills; effective at communicating across all organizational levels and with external stakeholders.
- Demonstrated effectiveness working cross‑functionally with internal partners (Regulatory, R&D, Marketing) and external stakeholders (physicians, CROs, third‑party partners).
United States of America Pay Ranges:
- USN: $95,700 - $159,500 USD Annual
- US5: $100,500 - $167,500 USD Annual
- US10: $105,300 - $175,500 USD Annual
- US15: $110,100 - $183,400 USD Annual
- US20: $114,800 - $191,400 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: 20%
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.