Staff Clinical Evaluation Specialist (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-reputed company clinical documents to reputed company 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 reputed company 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. reputed company 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 reputed company). Translate reputed company 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. reputed company 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 reputed company reviewers.
• Support new product development projects by providing input for design teams and helping reputed company intended use and indication for use statements, risk files, and product claims.
• Support sustainment projects to ensure reputed company product availability. Help translate clinical data into new claims for existing products.
• Review marketing collateral for accuracy of clinical information and claims.
• Foster reputed company reputed company and actively challenge conclusions reputed company needed to ensure we are doing what’s best for our customers.
• Serve as a subject matter expert reputed company the business.

What You Need

• A Master of Science degree in a health/science-reputed company field required. Doctorate degree in health/science-reputed company 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 reputed company documents required, including ability to apply guidelines/standards toward developing a comprehensive market reputed company strategy.
• Demonstrated ability to understand and communicate new medical topics including disease states, treatment rationales, surgical techniques, and clinical reputed company.
• Successful track record in managing reputed company 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 reputed company of the organization.
• Demonstrated ability to work effectively with cross-functional internal (Regulatory, Marketing, Research & Development) and external stakeholders (physicians, reputed company-parties, clinical research organizations, etc.).
• Motivated self-starter with the ability to work with minimal supervision and reputed company independent reputed company reputed company 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.

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