Documentation Control
Regulatory & Government Affairs
Location: Bengaluru
Work Mode: Hybrid
Company: Fresenius Medical Care
Job ID: R0252486
Role Overview
The Documentation Control role supports quality and regulatory documentation systems within the Global Management System (GMS).
The position focuses on:
Document lifecycle management
Electronic document management systems (eDMS)
Regulatory compliance documentation
Training coordination and records management
Quality system support for regulated industries
This role is important for ensuring controlled documentation complies with global standards and regulatory requirements.
Key Responsibilities
1. Document Control & Lifecycle Management
Maintain controlled documents and document retention systems
Support:
Change control processes
Document revisions
Formal document reviews
Ensure controlled documents remain current and compliant
2. Electronic Document Management Systems (eDMS)
Support systems such as:
QDOK
Windchill
MS Teams
SharePoint
Responsibilities include:
User management
Troubleshooting
Workflow support
Training users on systems
3. Controlled Document Updates
Execute document change requests
Perform controlled document updates
Coordinate review and approval workflows
4. Training & Compliance Support
Support regulatory training processes and systems
Maintain:
Training records
Compliance evidence
Ensure activities are completed within defined timelines
5. Local Implementation & Translation Support
Prepare Local Implementation Requests (LIRs)
Support translation and implementation of controlled documents across regions
6. Reporting & KPI Management
Prepare:
KPIs
Dashboards
Compliance reports
Presentations
Track documentation metrics and process effectiveness
7. Continuous Improvement Initiatives
Participate in workflow optimization projects
Support harmonization of legacy systems
Improve eDMS and documentation processes
Required Qualifications
Education
Bachelor’s degree in:
Scientific field
Medical field
Technical discipline
Related area
Experience
Minimum 5 years total experience
At least 3 years in:
Medical devices industry OR
Pharmaceutical industry
Technical Skills
Regulatory & Quality Standards
Knowledge of:
ISO 13485
ISO 9001
ISO 14001
GxP guidelines
MDSAP requirements
Documentation Systems
Experience with:
Electronic document management systems (eDMS)
Quality management tools
Controlled documentation workflows
Compliance & Quality
Document lifecycle management
Change control systems
Audit readiness support
Regulatory documentation practices
Behavioral Competencies
Strong attention to detail
Excellent organizational skills
Effective communication and coordination ability
Compliance-focused mindset
Ability to manage timelines and multiple documentation tasks
Process improvement orientation
Work Environment
Fresenius Medical Care offers:
Hybrid work model
Global regulatory and quality systems exposure
Cross-functional collaboration opportunities
Regulated healthcare industry environment
Role Summary (Simple View)
This role mainly involves:
Managing regulated documents and quality records
Maintaining electronic document systems
Supporting audits, training, and compliance activities
Ensuring documents follow regulatory standards
Coordinating document updates and approvals
Career Path Opportunities
Possible growth paths:
Documentation Specialist
Quality Systems Executive
Regulatory Affairs Associate
QA Documentation Lead
Global Quality Compliance Manager
If you want, I can also:
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