Quality & Regulatory Compliance Specialist

We’re Looking for a Quality & Regulatory Compliance Specialist

Are you someone who takes initiative, pays close attention to details, and has experience with quality management systems? Do you enjoy working with people and are you excited by new challenges? If that sounds like you, we’d love to meet you! Become a part of the Arjo Czech Republic team as a Quality & Regulatory Compliance Specialist and help us to take our Quality Management System to the next level.

Join Our Team!

• Become part of a stable international company with a globally recognized brand.
• Work in the field of medical devices with a company dedicated to the idea of Empowering Movement.
• Enjoy a friendly team environment and inspiring challenges.

What Will Your Job be About?

• maintain and improve the local Quality Management System - maintaining relevant trackers, updating/creating procedures and cooperation with other departments to coordinate the development of QRC procedures
• coordinate execution of Field Corrections and Recalls in Czech Republic and Slovakia markets
• monitor processes compliance against quality procedures & standards and manage local corrective actions to related activities
• interact with National Health Authority (SUKL)
• monitor applicable EU and national regulatory/legal requirements and initiate activities assuring regulatory compliance
• support qualification and maintenance of local Distributors, Service Suppliers and 3rd Party Products suppliers
• train employees on quality processes
• validate local marketing collateral
• report performance of the QMS to the CEE QRC Manager
• act as a backup for reporting Product Complaints and Service Repairs to dedicated digital complaint handling system
• provide administrative support for the management of CEE regional QMS

What Do We Expect from You?

• knowledge of Quality Management System principles (e.g. ISO 9001, ISO 13485)
• 2 years’ experience in Medical Device environment
• knowledge of regulation and legislation on Medical Devices (national and EU MDR)
• advanced English skills (B2)
• Polish language skills would be an asset
• demonstrable accuracy and attention to details
• ability to provide excellent administrative support
• ability to work independently with emphasis on prioritization and managing deadlines
• ability to demonstrate strong written & numerical skills
• practical knowledge of MS Office
• team player, cooperation & coordination spirit

Enjoy These Advantages

• a stable position in an international company
• flexible working hours
• performance-based bonuses
• a modern and comfortable office located in the heart of Prague
• remote work option available for employees outside Prague
• 5 weeks of vacation
• cafeteria benefits program worth a total of CZK 18,000 per year

Does this sound like the right opportunity for you?
Let us know! Send us your CV in English and a few motivational words!