Regulatory Project Manager

5 hours ago


Stockholm, Stockholm, Sweden TFS HealthScience Full time

Role Overview: Project Manager – MDR Compliance

TFS HealthScience is a leading global Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their clinical development journey. Our expertise includes full service capabilities, resourcing, and Functional Service (FSP) solutions.

The Project Manager – MDR Compliance is responsible for leading and coordinating efforts to ensure adherence to Medical Device Regulation (MDR) and related regulatory frameworks, including developing project plans, setting goals, managing resources, mitigating risks, and ensuring timely delivery within scope.

This role requires on-site presence as well as remote flexibility and is part of our SRS/FSP team dedicated to one sponsor.

Responsibilities:

  1. Lead and coordinate efforts to ensure adherence to Medical Device Regulation (MDR) and related regulatory frameworks.
  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:

  1. Minimum three years of experience in project management.
  2. Strong knowledge of MDR and regulatory compliance frameworks.
  3. Experience in implementing regulatory policies and management systems.
  4. Proven ability to lead teams and engage stakeholders.
  5. Strong communication and problem-solving skills.
  6. Fluency in both Swedish and English.

Benefits Package

A competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment where collaboration, innovation, and making a difference in the lives of patients are valued.



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