"Alerted.org

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. This position requires working independently with minimal supervision. Work flexibility is **Remote** , can be based remotely anywhere in **Canada.**

What you will do

+ Write/revise documents for regulatory submissions, pre-subs, annual reports, clinical evaluations, post-market clinical follow-up, summary of safety and clinical performance, post-market surveillance, and clinical studies to validate device safety and performance. Perform systematic literature reviews. Identify, appraise, and analyze relevant clinical, post-market surveillance, marketing, and preclinical testing data to create comprehensive scientific reviews, which may include in-depth quantitative analyses, qualitative analyses, and risk management cross-checks. Synthesize information in clinical documents in a clear, concise, and scientifically accurate manner. Maintain documentation throughout the product lifecycle.

+ Support evidence communication in partnership with stakeholders (e.g., Marketing, Clinical Research, Reimbursement & Market Access). Translate complex scientific and technical information into accessible content for various audiences, including regulatory bodies and customers. Support preparation of documents like manuscripts, conference presentations/posters, white papers, and customer-facing promotional materials.

+ Communicate and negotiate with regulators on clinical evidence requirements to ensure the successful acceptance of regulatory submissions. Lead issues to resolution.

+ Independently resolve document content issues and questions from external and internal reviewers. Coordinate and manage the cross-functional review process and ensure timely approvals from all reviewers.

+ Support new product development projects by providing input for design teams and helping develop intended use and indication for use statements, risk files, and product claims.

+ Support sustainment projects to ensure continued product availability. Help translate clinical data into new claims for existing products.

+ Review marketing collateral for accuracy of clinical information and claims.

+ Foster open dialogue and actively challenge conclusions when needed to ensure we are doing what’s best for our customers.

+ Serve as a subject matter expert within the business.

What you need

+ A Master of Science degree in a health/science-related field required. Doctorate degree in health/science-related field preferred.

+ 4+ years of industry experience in clinical, quality, or regulatory affairs (risk management, design quality, post-market safety, etc.), including 3 years of experience in writing clinical evaluations for medical devices required.

Preferred

+ Demonstrated ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents required, including ability to apply guidelines/standards toward developing a comprehensive market access strategy.

+ Demonstrated ability to understand and communicate new medical topics including disease states, treatment rationales, surgical techniques, and clinical outcomes.

+ Successful track record in managing complex projects.

+ Excellent scientific and medical writing skills required.

+ Strong communication, project management, influencing, and negotiation skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.

+ Demonstrated ability to work effectively with cross-functional internal (Regulatory, Marketing, Research & Development) and external stakeholders (physicians, third-parties, clinical research organizations, etc.).

+ Motivated self-starter with the ability to work with minimal supervision and make independent decisions when limited information is available.

+ Strong planning and organizational skills, attention to detail, and the ability to adapt and adjust to changing priorities.

+ Analytical and problem-solving capabilities with a strong technical aptitude, including the ability to draw insights from data quickly and to define executable actions.

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

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.