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Regulatory Affairs and Quality Lead

2 months ago

Stockholm, Stockholm, Sweden Elekta AB Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs and Quality Lead to join our team at Elekta AB. As a key member of our Regulatory Affairs and Quality Team, you will be responsible for overseeing and managing functions that support departmental initiatives and directives.

Key Responsibilities
  • Support the development and implementation of regional submission processes and regulatory roadmaps for the European region.
  • Provide strategic advice and interpretation of legislation to local organizations, ensuring compliance with regulatory requirements.
  • Lead and manage change initiatives, delivering results and aligning priorities.
  • Represent Elekta in international regulatory bodies, hosting external audits and interacting with national authorities.
  • Support locally appointed regulatory and quality staff in their interactions with national authorities and in preparations of submissions and compliance data.
  • Contribute to the onboarding of new regions, managing metrics and supporting the growth of the team.
Requirements
  • More than 5+ years of experience working with regulatory affairs in the European region.
  • Knowledge and proven track record in Regulatory Affairs for Medical Devices in the European region.
  • Knowledge of the European Directive for Medical Devices and experience of ISO 13485 would be preferred.
  • Degree equivalent in an engineering-related subject or a formal engineering apprenticeship with demonstrated experience in a similar role.
  • A positive attitude towards change and a commitment to promoting the global goals of the business.
What We Offer
  • A competitive salary and benefits package.
  • The opportunity to work for a leading MedTech company with a global presence.
  • A dynamic and innovative work environment with a focus on employee development and growth.
  • The chance to make a real difference in the lives of patients and healthcare professionals around the world.