Posted in

Senior Staff Clinical Evaluation Specialist

Senior Staff Clinical Evaluation Specialist

CompanyStryker
LocationPortage, MI, USA
Salary$100500 – $165600
TypeFull-Time
DegreesMaster’s
Experience LevelSenior, Expert or higher

Requirements

  • A Master of Science degree in a health/science-related field required.
  • Doctorate degree in health/science-related field preferred.
  • 7+ 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.
  • 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.
  • Demonstrated ability to drive innovation and set direction within the group in internal procedures and best practices.
  • Strong communication, project management, influencing, and negotiation skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.

Responsibilities

  • Act as the dedicated clinical evaluation project manager, driving the establishment of a coherent clinical evidence strategy throughout the new product development cycle.
  • 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.
  • Design compliant and sustainable literature search strategies, perform systematic reviews to capture and summarize published clinical data.
  • Form and justify conclusions regarding the overall benefit-risk profile of medical devices, in collaboration with a medical expert and other stakeholders, based on up-to-date US, European, and other regulatory requirements.
  • Communicate and negotiate with regulators on clinical evidence requirements to ensure the successful acceptance of regulatory submissions.
  • Analyze current medical and scientific trends in the clinical state of the art on a broad variety of specialized indications and techniques.
  • Lead evidence communication in partnership with stakeholders (e.g., Marketing, Clinical Research, Reimbursement & Market Access) to ensure alignment with business priorities.
  • Support clinical research activities by identifying gaps in knowledge and developing strategies for pre-clinical and clinical data collection.
  • Support new product development projects by helping cross-functional teams 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, product performance, and safety claims.
  • Proactively recognize potential scheduling and resource conflicts for projects and provide recommendations to resolve.
  • 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.

Preferred Qualifications

  • 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.
  • Ability to build strong relationships by fostering open communication, respect, and trust.
  • Act with a customer service/stakeholder-focused approach.