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. 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.

Travel Percentage: 10%