GRA CMC SaMD & Cybersecurity Specialist
Americas, US-PA, King of Prussia, CSL Behring, United States
USD 140K-164K (estimate) Mid-level Full Time
Tasks
- Advise on compliance requirements
- Conduct regulatory assessment and due diligence
- Coordinate regulatory submissions
- Develop and maintain policies and procedures
- Develop global regulatory strategies
- Engage with Health Authorities
- Implement international standards and regulations
- Lead cross-functional collaboration
- Manage regulatory communication
- Provide regulatory expertise to internal teams
- Review regulatory documentation
- Support global program planning
- Support product registration and lifecycle management
Perks/Benefits
- Employee development programs
- Global company culture
- Health insurance
- Inclusion and diversity opportunities
Skills/Tech-stack
Cybersecurity | Documentation Management | EU MDR | FDA | Global compliance | IEC 60601 | IEC 62304 | ISO 10993 | ISO 13485 | ISO 14971 | ISO 23640 | International regulations | Quality management | Regulatory Intelligence | Regulatory Submission | Regulatory strategy | Risk Management | Stakeholder Engagement | Team leadership | Technical writing
Education
Regions
Countries
States
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