Senior Staff Clinical Evaluation Specialist (Remote)
Core
Lead clinical evidence strategies and scientific documentation to support regulatory submissions, market access, and product lifecycle decisions for surgical technologies.
Role type
Senior Staff Clinical Evaluation Specialist
Builds
Clinical evidence packages, regulatory submissions, and scientific communications for medical devices
Domain
Medical device industry / Regulatory Affairs
Required skills
Clinical evaluation strategy, systematic literature reviews, evidence synthesis, benefit-risk assessment, regulatory submission support, scientific writing, cross-functional project management
Preferred skills
Global regulatory experience, scientific publication development, complex cross-functional project leadership
Technologies
None stated
Responsibilities
Lead clinical evidence strategies for new product development and lifecycle management; Author and maintain clinical evaluations, post-market reports, and regulatory submissions; Design and execute systematic literature reviews and synthesize clinical data; Assess benefit-risk profiles of medical devices; Partner with regulatory authorities and internal stakeholders; Mentor team members and improve clinical evaluation methodologies
Seniority
Senior Staff, hands-on IC with mentorship responsibilities
