Principal Regulatory Affairs Specialist - Global Harmonization Policy & Key Initiatives
Core
Lead global regulatory advocacy and policy strategy to advance harmonization of medical device regulations across geographies.
Role type
Principal Regulatory Affairs Specialist (Global Harmonization)
Builds
Enterprise-wide global regulatory advocacy strategies, white papers, and policy positions for medical devices.
Domain
Medical Device Industry / Global Regulatory Affairs
Required skills
Global regulatory policy analysis, cross-functional team leadership, stakeholder engagement, regulatory advocacy, white paper development, internal working group management, industry trend monitoring.
Preferred skills
Leading complex geographically dispersed teams, international regulatory requirements knowledge, healthcare policy advocacy, postmarket surveillance, MDSAP, clinical evidence, human factors.
Technologies
SharePoint, Global Regulatory Policy SharePoint
Responsibilities
Define and execute global regulatory advocacy strategies; lead development of white papers and talking points; comment on external regulatory documents; manage internal working groups; collaborate with regional teams on regulatory challenges; maintain global regulatory policy trackers.
Seniority
Principal, strategy & mentorship