Regulatory Affairs Leader - ARC
Core
Provides strategic regulatory leadership for ARC regulatory programs, including global RA support for registration planning, submissions, notified body and quality system audits, and program implementation.
Role type
Senior Regulatory Affairs Leader (ARC)
Builds
Global regulatory submissions and compliance programs for medical technology products
Domain
Medical Technology / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Strategic regulatory leadership, registration planning, submission management, quality system audit coordination, regulatory strategy development, advertising and promotion review, technical document writing, regulatory intelligence analysis, risk assessment, license/registration assessment
Preferred skills
Cross-functional team collaboration, problem-solving with technical expertise, consensus building, independent work in fast-paced environments, prioritization for data analysis
Technologies
None explicitly stated
Responsibilities
Provide strategic direction for ARC regulatory programs and global RA support; Develop regulatory strategies to optimize submission pathways; Review and approve advertising and promotion materials; Assess product changes to determine needs for new or revised licenses; Research and organize background information for submissions; Apply regulatory requirements for pre- and post-market compliance
Seniority
Senior, hands-on IC