Regulatory Affairs Manager

17 hours ago


Stockholm, Stockholm, Sweden TFS HealthScience Full time
About Us

We are TFS HealthScience, a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey.

Our team provides 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.

Job Description:

The Project Manager – MDR Compliance will lead and coordinate 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.

Responsibilities:
  1. Plan, execute, and complete projects related to MDR compliance
  2. Develop strategies to align with regulatory requirements
  3. Coordinate with cross-functional teams
  4. Ensure project milestones are met
  5. Manage risk assessment and mitigation strategies
  6. Communicate project updates to stakeholders and regulatory bodies
Requirements:
  • Three years of experience in project management
  • Strong knowledge of MDR and regulatory compliance frameworks
  • Experience in implementing regulatory policies and management systems
  • Ability to lead teams and engage stakeholders
  • Strong communication and problem-solving skills
  • Fluency in both Swedish and English


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