Regulatory Affairs Specialist

8 hours ago


Stockholm, Stockholm, Sweden TN Sweden Full time

TN Sweden is a mid-size Contract Research Organization (CRO) offering innovative solutions for biotechnology and pharmaceutical companies. Our services include full service capabilities, resourcing and Functional Service (FSP) solutions.

The Regulatory Affairs Specialist – MDR Compliance plays a crucial role in ensuring adherence to Medical Device Regulation (MDR) and related regulatory frameworks. Key responsibilities include developing project plans, setting goals, managing resources, mitigating risks, and ensuring timely delivery within scope.

Key Responsibilities:

  • Lead and coordinate projects related to MDR compliance
  • Develop and implement strategies to align with regulatory requirements
  • Collaborate 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

Qualifications:

  • 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

Our company values collaboration, innovation, and making a difference in the lives of patients.



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