Manager Documentation Services
Core
Leading documentation management activities to support new product development and manufacturing operations while ensuring compliance with global regulatory requirements.
Role type
Manager, Documentation Services
Builds
Compliant documentation systems, Device Master Records, and technical publications for medical diagnostics products.
Domain
Healthcare diagnostics / Regulatory compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
documentation management, change control, FDA/GMP/ISO compliance, budget management, resource allocation, staff hiring and retention, process improvement, Device Master Record maintenance, regulatory audit support
Preferred skills
delegation, database management tools, cross-division collaboration, matrixed environment navigation, goal setting, constructive feedback delivery, multitasking, organizational planning
Technologies
Electronic Document Management (EDM) systems, database management tools
Responsibilities
Manage daily department activities including priorities, schedules, and customer service; Define and allocate resources for project schedules; Develop and control department budget; Ensure compliance with ISO and 21CFR 820; Develop process flows for global documentation change control; Conduct research for legal litigation; Maintain and control Device Master Record; Provide records for regulatory audits; Troubleshoot documentation problems; Hire and retain staff; Comply with FDA regulations and company policies.
Seniority
Manager, hands-on leadership