Senior Manager, Instructional Design and Labeling Operations
Core
Lead the Instructional Design team to manage the lifecycle of Instructions for Use (IFUs), Native Artwork Files (NAFs), and related instructional artwork for regulated medical products.
Role type
Senior Manager, Instructional Design and Labeling Operations
Builds
IFUs, NAFs, and instructional artwork deliverables for combination products and regulated medical products
Domain
Biotechnology / Regulated Medical Products / Patient Education
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
People leadership, process ownership, stakeholder management, regulated medical product experience, vendor coordination, cross-functional collaboration
Preferred skills
Experience with Human Factors studies, Health Authority submission readiness, SOP governance
Technologies
None explicitly stated
Responsibilities
Lead, coach, and develop a team of Instructional Design Engineers; Own process governance and continuous improvement of SOP-437076; Provide oversight for development and revision of IFUs, NAFs, and instructional artwork; Manage vendor and contractor relationships; Partner with Human Factors, Regulatory Labeling, and Quality teams
Seniority
Senior Manager, people leadership and operational excellence
