Regulatory Project Coordinator

3 days ago


Stockholm, Stockholm, Sweden TFS HealthScience Full time

Overview:

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions, including expertise in Medical Device Regulation (MDR) compliance.

About the Role:

The Project Manager – MDR Compliance 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.

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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