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Project Delivery Specialist
6 hours ago
TFS HealthScience is a Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies worldwide. Our company offers full service capabilities, resourcing, and Functional Service (FSP) solutions for clients' entire clinical development journey.
Job Responsibilities
The Regulatory Affairs Manager will be responsible for leading and coordinating efforts to ensure adherence to Medical Device Regulation (MDR) and related regulatory frameworks. This includes developing project plans, setting goals, managing resources, mitigating risks, and ensuring timely delivery within scope and budget. This is a full-time position in a hybrid working setting, requiring on-site presence as well as remote flexibility.
Responsibilities:
- Develop and implement strategies to align with regulatory requirements
- Coordinate with cross-functional teams, including legal, quality assurance, and operations
- Ensure project milestones are met while maintaining high-quality standards
- Manage risk assessment and mitigation strategies
- Communicate project updates to stakeholders and regulatory bodies
Requirements:
- Minimum three years of experience in project management
- Strong knowledge of MDR and regulatory compliance frameworks
- Experience in implementing regulatory policies and management systems
- Proven ability to lead teams and engage stakeholders
- Strong communication and problem-solving skills
- Fluency in both Swedish and English
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