Regulatory Affairs Specialist

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.
vivien.urban@adaptivelifescience.com
+49 30 16639819

#LI-VU1