Regulatory Affairs Associate

at  CareDx Inc

The Regulatory Affairs Associate shall primarily perform the duties associated with the position in accordance with the Company’s instructions from time to time. The position is located at the CareDx office in Stockholm, travel may be required.

COMPETENCE REQUIREMENTS:

• Bachelor level (or higher) in a degree in Medical Science or equivalent
• The position puts high demands on being able to act independently but also effectively collaborating internally, as well as externally.
• The role requires an organized, structured, accurate, independent and pro-active way of working. You must have strong analytical and project management skills combined with a communicative ability and being detail oriented.

• Assist with and/or lead global product registrations
• System Administrator RegDesk RIMS (Regulatory Information Management System)
• Maintenance of IVDR Post Market Surveillance (PMS):
• Post Market Surveillance
• Post Market Performance Follow Up
• Periodic Safety Update
• Summary of Safety and Performance
• Reporting of Serious Incidents
• Assess deviations for vigilance impact
• Manage incident/vigilance reporting globally
• Manage EU Importer obligations
• Manage UDIs and Eudamed interactions
• Manage global translations of IFU, SDS and technical documentation (includes coordination of internal validation)
• Participate in Internal and third-party regulatory audits
• Monitoring of new regulatory and legal requirements to ensure compliance for commercially available products and products under development.
• Implementation and maintenance of RA SOPs
• Hold applicable in-house training sessions
• Other Regulatory Affairs tasks as applicable