Smith & Nephew Benefits Overview

Develops and executes global regulatory strategies for medical devices, manages submissions and product approvals, assesses manufacturing and product changes, and ensures lifecycle compliance. The role partners with product development and manufacturing teams, engages regulatory agencies, supports audits and regulatory intelligence, maintains procedures and databases, and mentors colleagues. Requires at least five years of regulatory affairs experience, strong knowledge of medical device regulations and design controls, and excellent technical writing, communication, analytical, and project management skills.

Lead product cybersecurity across medical devices, connected technologies, digital solutions, and software. Define security requirements, maintain threat models and risk registers, lead vulnerability and penetration testing, integrate automated security tools, mature secure development practices, support incident response, and provide technical leadership to regulators, customers, auditors, and security researchers. Collaborate across IT, R&D, compliance, and other business teams.

Leads enterprise digital quality systems supporting eDHR and Windchill PLM across global manufacturing operations. Responsibilities include process harmonization, system enhancements, governance, deployment, training, stakeholder alignment, data integrity, compliance, validation, audit readiness, feature prioritization, business requirements, and change control. The role serves as a business process owner and coordinates cross-functional initiatives across Quality, IT, Manufacturing, Engineering, and R&D in a regulated medical device environment.