Regulatory Affairs Specialist

Job type:Perm
Business Sectors:Regulatory Affairs
Job ref:24982
Post Date:26. 02. 2024

About the Role

Regulatory Affairs Specialist

Are you passionate about bringing safe and effective medical devices to market with speed and agility?

My client, a global leader in the design, manufacture, and distribution of cutting-edge mobility devices is seeking a promising Regulatory Affairs Specialist to join their European team.

Ready to put your skills to work?

Your Tasks:

  • Implement quality system components focused on regulatory compliance with MDR 2017/745, ISO 13485 and ISO 14971
  • Manage projects and activities for the improvement of products and processes from a regulatory standpoint
  • Monitor and ensure the compliance of regulatory requirements (Europe, Switzerland & UK)
  • Manage CAPA system, track recalls and FSCAs
  • Participate in risk assessment activities such as UFMEA
  • Collaborate with the Quality Director Europe to ensure documentation is compliant
  • Assist in liability claim investigation and document collection
Your profile:
  • Fluent in English and at least intermediate knowledge of German
  • 2+ years professional experience in regulatory affairs or quality management relating to medical devices
  • Thorough knowledge of regulatory requirements (e.g. MDR, ISO 13485 & ISO 14971)
  • Computer proficiency with MS Office
  • Strong communication skills, good organizational skills, analytical thinking and a high level of reliability

Please apply with your CV or contact Vivien Zsuzsanna Urban for further details on this opportunity and additional vacancies in R&D, Regulatory Affairs and Quality Management.
+49 30 16639819