Compliance Coordinator for EU Regulations

15 hours ago


Stockholm, Stockholm, Sweden TFS HealthScience Full time
About this role

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey.

We provide full service capabilities, resourcing, and Functional Service (FSP) solutions to support clients' needs in the field of medical devices and ensure compliance with regulatory frameworks such as MDR.

Job Summary:

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.

This is a full-time position (1.0 FTE) in a hybrid working setting, requiring on-site presence as well as remote flexibility.

As part of our SRS/FSP team, you will be dedicated to one sponsor.

Key Responsibilities:
  1. Oversee the planning, execution, and completion of projects related to MDR compliance
  2. Develop and implement strategies to align with regulatory requirements
  3. Coordinate with cross-functional teams, including legal, quality assurance, and operations
  4. Ensure project milestones are met while maintaining high-quality standards
  5. Manage risk assessment and mitigation strategies
  6. 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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