Apply on Employer Site

Smith+Nephew · 3 hours ago

Lead, Evidence Analysis, Evaluation & Communications (EAEC) - ENT

United States

Full-time

Remote

Senior Level, Lead/Staff

$123K/yr - $160K/yr

5+ years exp

Smith+Nephew is a company that designs and manufactures technology aimed at enhancing quality of life. The Lead, Evidence Analysis, Evaluation & Communications (EAEC) role is pivotal in translating clinical evidence into strategic impact, overseeing the development of critical evaluation reports, and collaborating with teams to ensure compliance and innovation in ENT technologies.

Medical Device

Comp. & Benefits

Responsibilities

Lead the development of Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), and Summary of Safety and Clinical Performance (SSCPs) in compliance with EU MDR and global standards

Conduct systematic literature reviews and data extraction to support clinical evaluations and regulatory submissions

Act as subject matter expert during audits and regulatory reviews, providing strategic input and supporting new product development decisions

Perform critical appraisal and synthesis of clinical and scientific data to support product claims and strategic decision-making

Manage product claims and ensure alignment with clinical evidence and regulatory standards

Translate complex data into accessible formats such as infographics, summaries, and training materials

Develop and lead evidence communication strategies for priority brands

Collaborate with internal teams and external partners to ensure alignment with business strategy and regulatory requirements

Qualification

Clinical Evaluation ReportsRegulatory evaluationScientific communicationLiterature reviewsData analysisBiomedical sciences degreeProject managementScientific writingCommunication strategiesCollaboration skills