Project Manager (Regulatory Affairs, Nordics, Remote)

Copenhagen, Capital Region
Posted 5 days, 6 hours ago
Project Management

About the role

Job summary

This role involves managing and coordinating Quality Assurance and Regulatory Affairs (QARA) projects across Nordic markets, ensuring compliance and timely market access in a regulated MedTech environment.

Qualifications

  • Bachelor’s degree in Business, Life Sciences, Engineering, Regulatory Affairs, or a related field.
  • Advanced degree or project management certification (e.g., PMP, PRINCE2) preferred.

Responsibilities

  • Plan and manage QARA-related projects to support regulatory compliance and market readiness.
  • Develop project plans, timelines, and risk registers aligned with business objectives.
  • Coordinate cross-functional teams including Quality Assurance, Regulatory Affairs, and Operations.
  • Track project progress and drive timely resolution of issues.
  • Support local market initiatives related to regulatory submissions and audits.
  • Ensure compliance with internal policies and regulatory standards.
  • Prepare project status updates for leadership and stakeholders.
  • Contribute to continuous improvement initiatives in project execution and QARA processes.

Skills

  • 4–6 years of experience in project management or regulatory support within a regulated industry.
  • Strong organizational and planning skills with attention to detail.
  • Excellent written and verbal communication skills.
  • Proficiency in project management and office tools.
  • Experience in Quality Assurance or Regulatory Affairs preferred.

Education

  • Required: Bachelor’s degree in a relevant field.
  • Preferred: Advanced degree or project management certification.

Tools

  • Standard project management and office tools.
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